NEURODYN MULTIWAVE, AUSSIE SPORT
Device Facts
| Record ID | K131629 |
|---|---|
| Device Name | NEURODYN MULTIWAVE, AUSSIE SPORT |
| Applicant | Ibramed Equipamentos Medicos |
| Product Code | IPF · Physical Medicine |
| Decision Date | Nov 26, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Neurodyn Multiwave and Aussie Sport Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain.
Device Story
Neurodyn Multiwave and Aussie Sport are programmable, multi-channel neuromuscular stimulators used in clinical settings by healthcare professionals. Devices deliver various electrical waveforms—including Russian, Aussie (burst-modulated alternating current), Interferential, TENS, Premodulated, Microcurrent, FES, and DC/Polarized currents—via electrodes applied to the patient. The Neurodyn Multiwave features 5 preset and 10 user-adjustable programs; the Aussie Sport provides four independent output channels. Operators adjust intensity and parameters based on patient needs and prescription settings. By delivering controlled electrical pulses, the devices stimulate nerves and muscles to manage pain, prevent atrophy, and facilitate rehabilitation. Output is controlled via a microprocessor-based interface with keyboard locking safety features. Clinical benefits include pain relief, improved gait, and muscle functional recovery.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, comparison of technological characteristics, and established safety profiles of predicate devices.
Technological Characteristics
ABS plastic housing with LCD display. Microprocessor-controlled electrical stimulation. Modalities: Russian, Aussie (1,000/4,000 Hz carrier, 1-120 Hz burst), Interferential, TENS, Premodulated, Microcurrent, FES, DC/Polarized. 4 output channels. Bivolt (100/240V, 50/60Hz) power. Double isolation for line current. Keyboard lock safety feature. Timer: 1-60 minutes. Biocompatible FDA-cleared electrodes.
Indications for Use
Indicated for partially paralyzed patients (leg/ankle stimulation for gait improvement); patients with chronic intractable pain, post-traumatic acute pain, or post-surgical pain; patients requiring muscle spasm relaxation, disuse atrophy prevention, blood circulation improvement, muscle re-education, or range of motion maintenance.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- Neurodyn/Neurodyn Aussie Powered Muscle Stimulator (K121369)
- 300 PV Complete Electrotherapy (K021100)
- Vectra Genisys (K031077)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in a bold, sans-serif font. The symbol is composed of three horizontal bars on the top and bottom, connected by a vertical bar in the center, creating a symmetrical design. The entire logo is in black against a white background.
# SECTION 6
# 510(k) Summary
Neurodyn Multiwave
510 (k) Number: K131629
Date of Submission: November 25, 2013
## Submitter:
IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil
TEL - 5519-3817-9633 FAX - 5519-7816-7980
## Official Contact:
Lilian Llull TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
TEL - (305) 377-0077
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k) premarket notification is in accordance with 21 CFR 807.87.
Common (Standard) Name: Powered Muscle Stimulator Neurodyn Multiwave; Aussie Sport Trade Name:
## Regulation Number & Product Codes:
GZJ - 21 CFR 882.5890-Transcutaneous electrical nerve stimulator for pain relief
- IPF 21 CFR 890.5850-Powered muscle stimulator
- LIH Interferential Current Therapy-Pre-amendment
- GZI- 21 CFR 882.5890-External functional neuromuscular stimulator
## Predicate Device Identification:
K121369 Neurodyn/Neurodyn Aussie Powered Muscle Stimulator K021100 300 PV Complete Electrotherapy K031077 Vectra Genisys
Predicate devices had been submitted and cleared by 510(k) for the same intended uses and
NOV 2 6 2013
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Image /page/1/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is composed of three horizontal bars connected by a vertical bar in the center, with the top and bottom bars having angled ends. Below the logo, the word "indications" is printed in a smaller font size.
# Device Description
Neurodyn Multiwave and Aussie Sport Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the following predicate devices: Vectra Genisys K031077, Neurodyn/Neurpdun Aussie K121369 and 400PV Complete K021100.
The Neurodyn Multiwave Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Aussie Sport Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current(MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.
# Indications for Use
# Neurodyn Multiwave-Indications for Use:
As a FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
# As a Russian device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
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Image /page/2/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in a bold, serif font. The symbol is composed of horizontal bars connected by vertical lines, creating a geometric design. The overall impression is modern and professional.
- ncrease local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
As a DC/Polarized device: -Relaxation of Muscle Spasm
## Aussie Sport- Indications for Use:
As an Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
## Essential Performance
Neurodyn Multiwave Muscle Stimulator produces the following currents: Russian/Aussie /Interferential /Tens /Premodulated / Microcurrent/FES/DC Polarized.
The Aussie Sport Muscle Stimulator produces an Aussie current.
# Summary of Safety and Effectiveness Conclusion
The Neurodyn Muscle Stimulators are substantially to the predicate devices. All five devices claim similar Indications for Use and Device Characteristics in technological design and materials. The Neurodyn Muscle Stimulators do not raise any new issues of Safety and Effectiveness based on their similarities. The devices have continually proven to be safe and effective and demonstrate intended product performance.
# Device Comparison Table
| Device name | Neurodyn<br>Multiwave | Neurodyn | 300 PV Empi | Vectra Genysis | Aussie Sport | Aussie |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|
| K Number | K131629 | K121369 | K021100 | K031077 | K131629 | K121369 |
| Manufacturer | Ibramed | Ibramed | Empi | Chattanooga | Ibramed | Ibramed |
| Indications for Use | As a FES device:<br>Stimulation of the<br>muscles in the leg<br>and ankle of<br>partially<br>paralyzed<br>patients to | | As a FES device:<br>Stimulation of<br>muscles in the leg<br>and ankle of<br>partially paralyzed<br>patients to provide<br>flexion of the foot | As a FES device:<br>Stimulation of<br>muscles in the leg<br>and ankle of<br>partially paralyzed<br>patients to<br>provide flexion of | | |
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Image /page/3/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized "I" shape above the word "IBRAMED" in bold, block letters. The "I" shape is made up of several horizontal bars and triangles, creating a geometric design.
| provide flexion of<br>the foot and thus<br>improve the<br>patient's gait. | and thus improve<br>the patient's gait. | the foot and thus<br>improve the<br>patient's gait. | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| As a TENS<br>device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br><br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain<br><br>As an<br>Interferential and<br>Premodulated<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain, or<br>acute post<br>traumatic surgical<br>pain<br><br>As a DC/Polarized<br>device:<br>Relaxation of<br>Muscle Spasm<br>As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of | As a TENS<br>device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br><br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain<br><br>As an<br>Interferential and<br>Premodulated<br>device:<br>Symptomatic<br>relief of chronic<br>pain, acute post<br>traumatic pain,<br>or acute post<br>traumatic<br>surgical pain<br><br>As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of<br>muscle spasms | As a NMES device:<br>Retarding or<br>preventing disuse<br>atrophy<br>Maintaining or<br>increasing range<br>of motion<br>Reeducating<br>muscles<br>Relaxation of<br>muscle spasm<br>Increasing local<br>blood circulation<br>Prevention of<br>venous thrombosis<br>of the calf muscles<br>immediately after<br>surgery<br><br>As a TENS device:<br>Symptomatic relief<br>of chronic (long<br>term) intractable<br>pain<br><br>Symptomatic relief<br>of post-traumatic<br>acute pain and<br>post surgical pain<br><br>As an<br>Interferential This<br>device is not been<br>used as a<br>predicate for the<br>Interferential<br>waveform | As a TENS device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br><br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain<br><br>As an<br>Interferential and<br>Premodulated<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain, or<br>acute post<br>traumatic surgical<br>pain<br><br>As a DC/ Mode<br>device:<br>Relaxation of<br>Muscle Spasm<br>As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of | | | | | | |
| muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re- | device:<br>Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain, or<br>acute post<br>traumatic surgical<br>pain | Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re- | device:<br>Symptomatic<br>relief of chronic<br>pain, acute post<br>traumatic pain, or<br>acute post<br>traumatic<br>surgical pain | | used as a<br>predicate for the<br>Interferential<br>waveform | muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re- | device:<br>Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain, or<br>acute post<br>traumatic surgical<br>pain | | |
| As a DC/Polarized<br>device:<br>Relaxation of<br>Muscle Spasm | | | As a DC/ Mode<br>device:<br>Relaxation of<br>Muscle Spasm | | | | | | |
| As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of<br>muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re-<br>education | As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of<br>muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re-<br>education | | As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of<br>muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re-<br>education | | | | | | |
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:
·
| | Maintaining or<br>increasing range<br>of motion | Maintaining or<br>increasing range<br>of motion | | Maintaining or<br>increasing range<br>of motion | | Maintaining or<br>increasing range<br>of motion | | | | | | | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|-----|--|-----|--|-----|--|
| | As an Burst<br>Modulated<br>Alternating<br>Current (Aussie)<br>device: | As a Burst<br>Modulated<br>Alternating<br>Current (Aussie)<br>device: | | As a Burst<br>Modulated<br>Alternating<br>Current (Aussie)<br>device: | | As an Burst<br>Modulated<br>Alternating<br>Current (Aussie<br>device: | | | | | | | |
| | Temporary<br>relaxation of<br>muscle spasms | Temporary<br>relaxation of<br>muscle spasms | | Temporary<br>relaxation of<br>muscle spasms | | Temporary<br>relaxation of<br>muscle spasms | | | | | | | |
| | Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions | Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions | | Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions | | Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions | | | | | | | |
| | Increase local<br>blood circulation | Increase local<br>blood circulation | | Increase local<br>blood circulation | | Increase local<br>blood circulation | | | | | | | |
| | Muscle re-<br>education | Muscle re-<br>education | | Muscle re-<br>education | | Muscle re-<br>education | | | | | | | |
| | Maintaining or<br>increasing range<br>of motion | | | | | Maintaining or<br>increasing range<br>of motion | | | | | | | |
| | Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain, or<br>acute post<br>traumatic surgical<br>pain | | | | | Symptomatic<br>relief of chronic<br>intractable pain,<br>acute post<br>traumatic pain,<br>or acute post<br>traumatic<br>surgical pain | | | | | | | |
| | As a Microcurrent<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain | As a Microcurrent<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain | | As a Microcurrent<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain | | As a Microcurrent<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain | | | | | | | |
| | Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | | Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | | Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | | | | | | | |
| Technological<br>characteristics<br>Medium-frequency<br>alternating current<br>(MFAC) | Identical | Identical | Identical | Identical | Identical | Identical | | | | | | | |
| Device Material | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | | | | | | | |
| Width (in) | 6.8 | 6.8 | 9.75 | 1.26 | 6.8 | 6.8 | | | | | | | |
| Height | | 4.9 | | 4.9 | | 8.75 | | 3.3 | | 4.9 | | 4.9 | |
| Depth | 12.4 | 12.4 | 12.75 | 4.5 | 12.4 | 12.4 | | | | | | | |
| Number of<br>Channels | 4 | 4 | 4 | 4 | 4 | 4 | | | | | | | |
| Temperature<br>range during<br>transport and<br>storage | 45°f-110°f | 45°f-110°f | -40 to 158°F | -40 to 150 F | 45°f-110°f | 45°f-110°f | | | | | | | |
| Environment<br>operating | 45°F-110°F | 45°F-110°F | 50° to 104°F | 45 to 105° F | 45°F-110°F | 45°F-110°F | | | | | | | |
.
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| temperature range | | | | | | |
|------------------------------------------------------|---------------------------------------|---------------------------------------|---------------------------------|---------------------------------------|---------------------------------------|--------------------------------------|
| Performance | Identical | Identical | Identical | Identical | Identical | Identical |
| Biocompatibility | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes |
| Mechanical Safety | Identical | Identical | Identical | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical | Identical | Identical | Identical |
| Russian | Yes | Yes | No | Yes | No | No |
| Aussie | Yes | Yes | No | Yes | Yes | Yes |
| Interferential | Yes | Yes | Yes | Yes | No | No |
| Microcurrent | Yes | Yes | No | Yes | No | No |
| TENS | Yes | Yes | Yes | Yes | No | No |
| Premodulated | Yes | Yes | Yes | Yes | No | No |
| FES | Yes | No | Yes | Yes | No | No |
| DC/Polarized | Yes | No | No | Yes | No | No |
| Voltage Input | 100/240V<br>50/60Hz<br>Bivolt | 100/240V<br>50/60Hz<br>Bivolt | 3.0V DC | 100/240V<br>50/60Hz<br>1.0A | 100/240V<br>50/60Hz<br>Bivolt | 100/240V<br>50/60Hz<br>Bivolt |
| Output | 5A+17V | 5A+17V | 1.0A+3.0V DC | 7.3A+24V | 5A+17V | 5A+17V |
| Method of line<br>current isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation |
| Patient leakage<br>control-normal<br>condition | 0.0508mA | 0.0508mA | 0.0502mA | 69μA | 0.0508mA | 0.0508mA |
| Patient leakage<br>current-single<br>fault condition | 0.0252mA | 0.0252mA | 0.0248mA | 31μA | 0.0252mA | 0.0252mA |
| Software<br>microprocessor | Yes | Yes | Yes | Yes | Yes | Yes |
| Automatic<br>overload trip | No | No | No | No | No | No |
| Automatic shutoff | No | No | No | No | No | No |
| Locking feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature |
| Treatment timer | 1 to 60 minutes | 1 to 60 minutes | 5 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes |
| Auto test and<br>repeat | Treatment timer<br>with auto shut off | Treatment timer<br>with auto shut off | Treatment timer | Treatment timer<br>with auto shut off | Treatment timer<br>with auto shut off | Treatment time<br>with auto shut off |
| Frequency Range | 50/60Hz | 50/60Hz | --- | 50/60Hz | 50/60Hz | 50/60Hz |
| Maximum Current<br>Density | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA |
# Conclusion
This premarket notification is being submitted to request clearance for the Neurodyn Muscle Stimulators. The analysis on the device demonstrates substantial equivalence to the Ibramed Neurodyn, Vectra Genisys, and EMPI 300 PV.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Ibramed Equipamentos Medicos c/o Ms. Lilian Llull Techlink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
Re: K131629
Trade/Device Name: Neurodyn Multiwave and Aussie Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH, GZI Dated: October 25, 2013 Received: October 28, 2013
Dear Ms. Llull:
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
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Page 2 - Ms. Lilian Llull
device-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
# Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
## 510(k) Number (if known): K131629
## Device Name: Neurodyn Multiwave and Aussie Sport
## Indications For Use:
## Neurodyn Multiwave - Indications for Use:
As a FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion ، of the foot and thus improve the patient's gait.
## As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain ı
- Symptomatic relief of post-traumatic acute pain and post-surgical pain ー
#### As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic । surgical pain
As a Russian device:
- Temporary relaxation of muscle spasms l
- Prevention or retardation of disuse atrophy in post-injury type conditions l
- Increase local blood circulation l
- Muscle re-education l
- Maintaining or increasing range of motion -
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms -
- Prevention or retardation of disuse atrophy in post-injury type conditions 1
- Increase local blood circulation -
- l . Muscle re-education
- Maintaining or increasing range of motion l
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
#### As a Microcurrent device:
- Symptomatic relief of chronic intractable pain r
- Symptomatic relief of post-traumatic acute pain and post-surgical pain -
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As a DC/Polarized device: .
- Relaxation of Muscle Spasm -
## Aussie Sport - Indications for Use:
As an Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms -
- Prevention or retardation of disuse atrophy in post-injury type conditions -
- -Increase local blood circulation
- Muscle re-education -
- Maintaining or increasing range of motion -
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic u surgical pain
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of Center for Devices and Radiological Health (CDRH)
# Joyce M. Whang -S
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