Who is the manufacturer of L300 Go System?

Bioness, Inc. filed the 510(k) submission for L300 Go System (K162407).

What is the FDA product code for L300 Go System?

GZI. It is classified under 21 CFR 882.5810 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for L300 Go System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for L300 Go System?

NESS L300 Plus System (K103343); NESS L300 System (K122784); WalkAide System (K140886).

Who can help prepare an FDA 510(k) submission like L300 Go System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

L300 Go System

K162407 · Bioness, Inc. · GZI · Jan 27, 2017 · Neurology

Device Facts

Record ID	K162407
Device Name	L300 Go System
Applicant	Bioness, Inc.
Product Code	GZI · Neurology
Decision Date	Jan 27, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5810
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension: thus, it also may improve the individual's gait. The L300 Go System may also: Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow

Device Story

L300 Go System is an external functional neuromuscular stimulator for gait improvement and muscle rehabilitation. System components: functional stimulation cuffs (lower leg/thigh) with surface electrodes; external pulse generators (EPG); control unit; optional gait sensor; clinician programming software. Input: motion sensor data (lower leg EPG) or gait sensor data (heel events) to trigger stimulation. Operation: EPG delivers biphasic electrical stimulation to muscles to facilitate dorsiflexion or knee flexion/extension. Used in clinics (clinician configuration) and by patients (daily use). Clinician uses tablet/PC software to program stimulation parameters. Patient uses control unit or stimulator-based interface to manage settings and monitor status. Benefits: improved gait, muscle re-education, prevention of disuse atrophy, maintenance of joint range of motion, increased local blood flow.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing.

Technological Characteristics

External functional neuromuscular stimulator. Materials: Bay State Polymer PA-2000RX (remote/EPG), biocompatible fabric over POM Hi plastic skeleton (lower leg cuff), TPU (thigh cuff), ABS (foot sensor). Energy: Battery-operated. Connectivity: Bluetooth Low Energy. Stimulation: Biphasic symmetric/asymmetric waveforms, current-regulated, 1-2 channels. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FCC Part 15.

Indications for Use

Indicated for adult and pediatric individuals with foot drop (ankle dorsiflexion) and/or adult individuals with muscle weakness related to upper motor neuron disease/injury (knee flexion/extension).

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

NESS L300 Plus System (K103343)
NESS L300 System (K122784)
WalkAide System (K140886)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 27, 2017 Bioness Inc. % Evan L. Rosenfeld, M.D., J.D. Regulatory Consultant MDJD Consulting 5905 Warm Mist Ln. Dallas. Texas 75248 Re: K162407 Trade/Device Name: L300 Go System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: December 16, 2016 Received: December 21, 2016 Dear Evan L. Rosenfeld, M.D., J.D.: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ Page 2 - Evan L. Rosenfeld, M.D., J.D. related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Carlos L. Pena -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K162407 Device Name L300 Go System #### Indications for Use (Describe) The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension: thus, it also may improve the individual's gait. The L300 Go System may also: - Facilitate muscle re-education - · Prevent/retard disuse atrophy - · Maintain or increase joint range of motion - · Increase local blood flow | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Exportation (to Part 370.2(a) Subject to the EAR) On-Site Consumption (to 370.2(a) Subject to the EAR) |× | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange star-like symbol on the left, followed by the word "Bioness" in gray. Below "Bioness" is the text "LiveOn" also in gray. The logo is simple and modern, with a focus on the company name. ## 510(k) Summary Bioness Inc. L300 Go System 510(k) Summary: L300 Go System Company name: Bioness Inc. #### Contact person: Mercedes Bayani Global Director, Regulatory Affairs Bioness Inc. Office Number: (661) 902-5324 Fax Number: (661) 362-4852 Email: mercedes.bayani@bioness.com 25103 Rye Canyon Loop Valencia, CA 91355, U.S.A. #### Application Correspondent: Evan L. Rosenfeld, M.D., J.D. Regulatory Consultant for Bioness Inc. MDJD Consulting Office Number: (972) 239-7021 Fax Number: (972) 239-7021 Email: evanrosenfeld2@sbcglobal.net #### Date prepared: January 27, 2017 Trade Name: L300 Go System Classification name: External functional neuromuscular stimulator Class: Il {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Bioness. To the left of the word "Bioness" is a symbol that looks like a sun or asterisk. Below the word "Bioness" is the text "LiveOn". #### Panel Identification: Neurology Product code: GZI and IPF #### Regulation number: 21 CFR § 882.5810 External functional neuromuscular stimulators 21 CFR § 890.5850 Powered muscle stimulators #### Predicate devices: - 1. Company: Bioness Neuromodulation Ltd. Device: NESS L300 Plus System (K103343) - 2. Company: Bioness Neuromodulation Ltd. Device: NESS L300 System (K122784) - 3. Company: Innovative Neurotronics, Inc. Device: WalkAide System (K140886) ### Purpose of the traditional 510(k) notice: The L300 Go System is a new device that is substantially equivalent to its own prior generation devices, the NESS L300 Plus System, the NESS L300 System and the Innovative Neurotronics, Inc. WalkAide System. ### Device description: The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's qait. The L300 Go System consists of: - 1. One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for Bioness. The logo consists of an orange star-like symbol on the left, followed by the word "Bioness" in gray. Below "Bioness" is the text "LiveOn" in a smaller font size. The logo is simple and modern, with a focus on the company name. - 2. External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events. - 3. A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status. - 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient. - 6. A power supply with two USB outputs and a proprietary cable to charge the EPG. #### Indications for use: The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The L300 Go System may also: - Facilitate muscle re-education ● - Prevent/retard disuse atrophy . - Maintain or increase joint range of motion - Increase local blood flow {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, with a small orange dot above the "i". Below "Bioness" is the text "LiveOn" in a smaller, lighter gray font. ### Substantial Equivalence: ### Table 1.0 Basic Unit Characteristics | | Current submission L300 Go System | Predicate L300 Plus System | Predicate L300 System | Predicate WalkAide System | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. 510(k) Number and Indication for Use | K162407 The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in individuals with muscle weakness related to upper neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it may also improve individual's gait. | K103343 The Ness L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and flexion or extension, thus it may improve the individual's gait. | K122784 The Ness L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals ( adult and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the Ness L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot . | K140886 The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. walking ability. | | | The L300 Go System may also: facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow | The L300 Plus System may also: facilitate muscle reeducation prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | The Ness 300 may improve : gait, facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | Medical benefits of Functional Electrical Stimulation (FES) may include: prevent /retardation of disuse atrophy increased local blood flow, muscle reeducation, and maintained or increased joint range of motion | | 2. Device Name, Model | L300 Go | L300 Plus | L300 | WalkAide | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller gray font below "Bioness". The sun-like symbol is made up of several orange lines that converge towards the center. | 3. Manufacturer | Bioness Inc. 25103 Rye Canyon Loop, Valencia, CA 91355 | Bioness Neuromodulation, a Bioness Inc. company 8 Hanagar Street, Hod Hasharon, 4501309 Israel | Bioness Neuromodulation, a Bioness Inc. company 8 Hanagar Street, Hod Hasharon, 4501309 Israel | Innovative Neurotronics 4999 Aircenter Cir #103, Reno, NV 89502 | | |-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------| | 4. Power Source(s) | Battery operated | Battery operated | Battery operated | Battery operated | | | - Method of Line Current Isolation | N/A (Battery operated) | N/A (Battery operated) | N/A (Battery operated) | N/A (Battery operated) | | | - Patient Leakage current | As required by IEC 60601-1 | As required by IEC 60601-1 | As required by IEC 60601-1 | Information is not available | | | o Normal condition | Less than 1.0 µA | Less than 1.3 µA | Less than 1.3 µA | Information is not available | | | o Single fault condition | 3.0 µA | 9.5 µA | 9.5 µA | Information is not available | | | 5. Number of output modes | Two modes: Biphasic Symmetric and Biphasic Asymmetric. | Two modes: Biphasic Symmetric and Biphasic Asymmetric. | Two modes: Biphasic Symmetric and Biphasic Asymmetric. | One Mode: Biphasic Asymmetric. | | | | Applicable to both lower leg and thigh position of the device. | Applicable to both lower leg (L300 RFS) and thigh (Thigh RFS) position of the device. | Applicable to lower leg only. | Applicable to lower leg only. | | | 6. Number of output channels | Lower leg small cuff – 1 channel | Lower leg small cuff – 1 channel (L300 RFS) | Lower leg small cuff – 1 channel (L300 RFS) | Lower leg cuff – 1 channel | | | | Lower leg regular cuff – 1 or 2 channels (in 2 channel configuration, both channels function as a single channel with separately adjustable medial / | Lower leg regular cuff – 1 channel | Lower leg regular cuff – 1 channel | Lower leg regular cuff – 1 channel | | | | lateral stimulation intensity) Thigh cuff – 1 channel | Thigh cuff – 1 channel (Thigh RFS) | N/A | N/A | | | - Synchronous or Alternating? | Alternating (at one time only one channel is activated) | N/A | N/A | N/A | | | - Method of Channel Isolation | Isolation between lower leg and thigh cuff stimulators: Thigh and Lower cuffs are stimulated by different battery operated EPG's without galvanic connection between them. | Isolation between lower leg and thigh cuff stimulators: Thigh and Lower cuffs are stimulated by different battery operated RFS units without galvanic connection between them. | N/A | N/A | | | | Isolation between channels within the same stimulator: channels in the same EPG are switched using high voltage FET switches. | N/A | N/A | N/A | | | 7. Regulated current or regulated voltage? | Current | Current | Current | Voltage | | | 8. Software / Firmware / Microprocessor Control? | Yes | Yes | Yes | Yes | | | 9. Automatic Overload Trip? | Yes | Yes | Yes | No | | | 10. Automatic No-Load Trip | Yes | Yes | Yes | No | | | 11. Automatic Shut off? | Yes | Yes | Yes | No | | | 12. Patient Override Control? | Yes | Yes | Yes | Yes | | | 13. Indication Display | Yes | Yes | Yes | Yes | | | - On/Off Status | Yes | Yes | Yes | Yes | | | - Low battery | Yes | Yes | Yes | Yes | | | - Voltage / Current Level? | Yes | Yes | Yes | Yes | | | 14. Timer range (minutes) | Gait mode: 1-10 seconds Max stimulation duration (clinician selectable) Training mode: 5-60 minutes | Gait mode: 2-10 seconds Max stimulation duration (clinician selectable) Training mode: 5-60 minutes | Gait mode: 2-10 seconds Max stimulation duration (clinician selectable) Training mode: 5- 60 minutes | Gait mode: 0.2-3 seconds Max stimulation duration (clinician selectable) Exercise mode: 1-30 minutes | | | 15. Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FCC part 15 subpart C and B1 | IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-10, FCC part 15 subpart C and B1 | IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-10, FCC part 15 subpart C and B1 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | | | 16. Compliance with 21 CFR 898? | Yes | Yes | Yes | Yes | | | 17. Weight | Control Unit: 60 g EPG: 60 g | Control Unit: 45 g L300 RFS: 50 g Thigh RFS: 50 g | Control Unit: 45 g L300 RFS: 50 g | Control Module: 88 g | | | | Lower leg FSC:150 | L300 FSC: 150 g | L300 FSC: 150 g | N/A | | | | g | Thigh FSC: 330 g | Gait Sensor: 30 g | Gait Sensor: 30 g | Control Module: | | | Thigh cuff: 300 g | | | | | | | Foot Sensor: 25 g | | | | | | 18. Dimensions [W x H x D] | Control Unit: 75x40x17 mm | Control Unit: 73x46x18 mm | Control Unit: 73x46x18 mm | Control Module: 82x61x21 mm | | | | EPG: 82x47x15 mm | L300 RFS: 74x43x15 mm Thigh RFS: 74x43x15 mm | L300 RFS: 74x43x15 mm | | | | | Lower leg FSC: 160x100x125 mm Thigh FSC: Length: 200 mm Circumference (min): Proximal panel: 270 mm Distal panel (regular): 310 mm Foot Sensor (dimensions of the Transmitter): 65x50x10: mm | L300 FSC: 160x100x125 mm Thigh FSC: Length: 170-260 mm Circumference (min): Proximal panel: 240 mm Distal panel (regular): 300 mm Gait Sensor (dimensions of the | L300 FSC: 160x100x125 mm Gait Sensor (dimensions of the Transmitter): 80x50x10 mm | | | | | | Transmitter): 80x50x10 mm | | | | | 19. Housing Materials and Construction | Remote Control: Bay State Polymer PA-2000RX | Control Unit: PC-ABS | Control Unit: PC-ABS | Control Module: ABS | | | | EPG: Bay State Polymer PA- 2000RX (Polycarbonate + ABS) | L300 RFS: polyamide 12 with 30% glass fibers reinforcement + Transparent ABS Thigh RFS: PC- ABS | L300 RFS: polyamide 12 with 30% glass fibers reinforcement + Transparent ABS | | | | | Lower Leg FSC: Biocompatible fabric over plastic (POM Hi) skeleton Thigh FSC: TPU | L300 FSC: Biocompatible fabric over plastic (POM Hi) skeleton. | L300 FSC: Biocompatible fabric over plastic (POM Hi) skeleton. | | | | | Foot Sensor: ABS (Sensor housing), Bay state Polymer PA-2000RX (Electronics housing) | Thigh FSC: TPU Foot Sensor: ABS | Foot Sensor: ABS | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, block letters. Below "Bioness" is the phrase "LiveOn" in a smaller, lighter font. The logo is clean and modern, with a focus on the company name and tagline. # Section 5 Section 5 510(k) Summary {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Bioness. The logo features a stylized sun-like symbol on the left, composed of several curved lines in an orange color. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the tagline "LiveOn" in a smaller, lighter font. # Section 5 Section 5 510(k) Summary {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray. Below "Bioness" is the text "LiveOn" in a smaller font size, also in gray. The logo is simple and modern, with a focus on the company name. #### Table 2a. Output Specifications (Mode 1 – biphasic symmetrical output) | MODE 1 – BIPHASIC SYMMETRICAL | Current submission L300 Go System | Predicate L300 Plus System | Predicate L300 System | Predicate WalkAide System | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | 1. Waveform | Biphasic Symmetrical | Biphasic Symmetrical | Biphasic Symmetrical | Biphasic Asymmetrical only | | 2. Shape | Rectangular | Rectangular | Rectangular | N/A | | 3. Maximum Output Voltage (+/- 10%) | Lower leg: 50V @ 500 Ω Thigh: 50V @ 500 Ω | Lower leg: 40V @ 500 Ω Thigh: 50V @ 500 Ω | Lower leg: 40V @ 500 Ω Thigh: N/A | N/A | | | Lower leg: 130V @ 2 kΩ Thigh: 130V @ 2 kΩ | Lower leg: 120V @ 2 kΩ Thigh: 120V @ 2 kΩ | Lower leg: 120V @ 2 kΩ Thigh: N/A | N/A | | | Lower leg: 130V @ 10 kΩ Thigh: 130V @ 10 kΩ | Lower leg: 120V @ 10 kΩ Thigh: 120V @ 10 kΩ | Lower leg: 120V @ 10 kΩ Thigh: N/A | N/A | | 4. Maximum Output Current (+/- 10%) | Lower leg: 100mA @ 500 Ω Thigh: 100mA @ 500 Ω | Lower leg: 80mA @ 500 Ω Thigh: 100mA @ 500 Ω | Lower leg: 80mA @ 500Ω Thigh: N/A | N/A | | | Lower leg: 65mA @ 2 kΩ Thigh: 65mA @ 2 kΩ | Lower leg: 60mA @ 2 kΩ Thigh: 60mA @ 2 kΩ | Lower leg: 60mA @ 2 kΩ Thigh: N/A | N/A | | | Lower leg: 13mA @ 10 kΩ Thigh: 13mA @ 10 kΩ | Lower leg: 12mA @ 10 kΩ Thigh: 12mA @ 10 kΩ | Lower leg: 12mA @ 10 kΩ Thigh: N/A | N/A | | 5. Pulse width | 100, 150, 200, 250, 300 µs (each: positive and phase) | 100, 200, 300 µs (each: positive and phase) | 100, 200, 300 µs (each: positive and phase) | N/A | | | Interphase period µs: 50, 100, 200 Total pulse duration: 250, 350, 450, 550, 650 µs (for interphase | Interphase period µs: 50 Total pulse duration: 250, 450, 650 µs | Interphase period µs: 50 Total pulse duration: 250, 450, 650 µs | | | 6. Frequency | interval of 50 µs) 10, 15, 20, 25, 30, 35, 40, 45 Hz | 20, 25, 30, 35, 40, 45 Hz | 20, 25, 30, 35, 40, 45 Hz | N/A | | 7. For interferential modes only: Beat Frequency. | N/A | N/A | N/A | N/A | | 8. For multiphasic waveforms only: | Yes | Yes | Yes | N/A | | - Symmetrical phases? | Yes | Yes | Yes | N/A | | - Phase Duration | Positive phase: 100, 150, 200, 250, 300 µs Negative phase: 100, 150, 200, 250, 300 µs | Positive phase: 100, 200, 300 µs Negative phase: 100, 200, 300 µs | Positive phase: 100, 200, 300 µs Negative phase: 100, 200, 300 µs | N/A | | 9. Net Charge (µC per pulse) @ 500 Ω | 0 µC, using inverted balanced phases | 0 µC, using inverted balanced phases | 0 µC, using inverted balanced phases | N/A | | 10. Maximum Phase Charge (µC) @ 500 Ω | Lower leg: $300 \text{ µs } * 100 \text{ mA } =$ 30 µC Thigh: $300 \text{ µs } * 100 \text{ mA } =$ 30 µC | Lower leg: $300 \text{ µs } * 80 \text{ mA } =$ 24 µC Thigh: $300 \text{ µs } * 100 \text{ mA } =$ 30 µC | Lower leg: $300 \text{ µs } * 80$ $\text{mA } = 24 \text{ µC}$ Thigh: N/A | N/A | | 11. Maximum Current Density @ 500 Ω | Maximum current levels are: Lower leg: 16.43 mA (rms) Thigh: 16.43 mA (rms) Maximum current density is: Lower leg (small cuff): 1.63 mA/cm² (rms), for smallest electrodes area of 10.1 cm² Lower leg (regular cuff): 1.04 mA/cm² (rms), for smallest electrodes area of 15.8 cm² Thigh: 0.23 mA/cm² (rms), for smallest electrodes area of 72 cm² | Maximum current levels are: Lower leg: 13.15 mA (rms) Thigh: 16.43 mA (rms) Maximum current density is: Lower leg (small cuff): 1.30 mA/cm² (rms), for smallest electrodes area of 10.1 cm² Lower leg (regular cuff): 0.83 mA/cm² (rms), for smallest electrodes area of 15.8 cm² Thigh: 0.23 mA/cm² (rms), for smallest electrodes area of 72 cm² | Maximum current levels are: Lower leg: 13.15 mA (rms) Thigh: N/A Maximum current density is: Lower leg (small cuff): 1.30 mA/cm² (rms), for smallest electrodes area of 10.1 cm² Lower leg (regular cuff): 0.83 mA/cm² (rms), for smallest electrodes area of 15.8 cm² Thigh: N/A | N/A | | 12. Maximum Power Density @ 500 Ω | Lower leg (small cuff): 13.4 mW/cm², for smallest electrodes area of 10.1 cm² Lower leg (regular cuff):…

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