MStim Drop Model: LGT-233
Device Facts
| Record ID | K202110 |
|---|---|
| Device Name | MStim Drop Model: LGT-233 |
| Applicant | Guangzhou Longest Science & Technology Co., Ltd. |
| Product Code | GZI · Neurology |
| Decision Date | Nov 5, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device 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 MStim Drop LGT-233 may also: Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow
Device Story
Wearable FES device; treats foot drop via electrical stimulation of leg muscles. Components: stimulator unit, electrode lead wire, electrode pads, leg bandage, battery charger. Operates in two modes: Training (seated/lying, muscle recovery/atrophy prevention) and Walk (gait assistance). Input: gait swing phase detection (Walk mode). Output: biphasic square pulse electrical stimulation. Controlled via manufacturer-provided mobile APP for stimulation/time settings. Used by patients; prescribed by physicians. Benefits: improved gait, muscle atrophy prevention, increased blood flow, joint range of motion maintenance.
Clinical Evidence
Bench testing only. Evaluated per IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (nerve/muscle stimulators), ANSI IEEE C63.27 (wireless coexistence), IEC 62133-2 (battery safety), and ISO 10993-5/10 (biocompatibility/cytotoxicity/sensitization).
Technological Characteristics
Wearable FES stimulator; ABS housing. Biphasic square waveform; regulated voltage. Frequency 10-80Hz; pulse width 50-500µs. Battery-powered (3.7V, 1200mAh Li-ion). Connectivity: APP-based control. Biocompatible electrodes/belts (ISO 10993). Safety: IEC 60601-1, 60601-2-10, 60601-1-2, 60601-1-11.
Indications for Use
Indicated for individuals with foot drop due to upper motor neuron injury. Provides ankle dorsiflexion and/or knee flexion/extension to improve gait. Additional uses: prevent/retard disuse atrophy, maintain/increase joint range of motion, increase local blood flow.
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
Submission Summary (Full Text)
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November 5, 2021
Guangzhou Longest Science & Technology CO., Ltd. % Jet Li Regulation Manager Guangzhou Keda Biological Tech Co., Ltd. 6F, No. I TianTai road, Science City, LuoGang District Guangzhou, Guangdong 510060 China
Re: K202110
Trade/Device Name: MStim Drop Model: LGT-233 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: October 5, 2021 Received: October 6, 2021
Dear Jet Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K202110
Device Name MStim Drop Model: LGT-233
Indications for Use (Describe)
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device 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 MStim Drop LGT-233 may also:
·Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
•Increase local blood flow
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary 510K number: K202110
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
#### Date of the summary prepared: November 04, 2021 1.
#### Submitter'sInformation 2.
Company Name: Guangzhou Longest Science & Technology CO., Ltd. Address: 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530 Guangzhou, Guangdong Province, P.R. China Phone: +86 020 6635 3999 Fax:+86 020 6635 3920 URL: www.longest.cn
E-mail: qzlongest@126.com
Contact Person: Xiaobing Luo (Deputy general manager) E-mail: service@longest.cn
# Application Correspondent:
Company: Guangzhou KEDA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity, China
Contact Person: Mr. Jet Li
Tile: Regulation Manager
Tel: +86-18588874857
Email: med-jl@foxmail.com
#### 3. Subject Device Information
Type of 510(k) submission: Traditional Common Name: External functional neuromuscular stimulator Trade Name: MStim Drop Model: LGT-233 Classification Name: Stimulator, neuromuscular, external functional; Stimulator, muscle, powered Review Panel: Neurology, Physical Medicine Product Code: GZI, IPF
Requlation Number: 882.5810, 890.5850
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### Regulation Class: 2
| Sponsor | Bioness Inc | Otto Bock Healthcare<br>Products GmbH |
|----------------------|--------------------------------------|----------------------------------------|
| Device Name | L300 Go System | Otto Bock Healthcare<br>Products GmbH |
| 510(k) Number | K162407 | K141812 |
| Product<br>Code | GZI, IPF | GZI; GZI |
| Regulation<br>Number | 21 CFR §882.5810<br>21 CFR §890.5850 | 21 CFR 882.5850 and<br>21 CFR 882.5810 |
| Regulation<br>Class | 2 | 2 |
#### Predicate Device Information 4.
# 5. Device Description
The MStim Drop LGT 233 is a wearable foot drop device, which is mainly consist s of stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger. The stimulator main unit can be charge by the battery charger.
The device can control the out stimulation and treatment time setting by APP application provided by the manufacturer, and it can trigger and control the pulse stimulation on and off by detecting the swing phase of gait during walking. The device was design to use FES (Functional Electrical Stimulation) to treat and improve the patient s foot drop and help to improve walking ability. It has two modes: Training mode, Walk mode. Training mode is suitable for muscle training when the patient is seated or lying down (patient lacking active training), which can promote muscle recover, prevent muscle atrophy, improve joint range of motion, and increase local blood flow. Walk mode is walking with the electrical stimulation.
#### 6. Intended Use / Indicationsfor Use
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device 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 MStim Drop LGT-233 may also:
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
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· Increase local bloodflow
#### 7. Test Summary
The Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1-2: 2014: Medical Electrical Equipment -Part 1-2: General requirements for basic salety 1. and essential performance. Collateral Standard: Electromagnetic Compatibility
- IEC 60601-1:2005: Medical Electrical Equipment Part 1: General requirements for basic safety 2. and essential performance
- 3. IEC 60601-1-11: 2015: Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- 4. IEC 60601-2-10: 2012: A1 2016 Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- 5. ANSI IEEE C63.27-2017: American National Standard for Evaluation of Wireless Coexistence
- 6. IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
- 7. Biological evaluation ofmedical device Part 10: Tests for irritation and skin sensitization(ISO 10993-10:2010)
- 8. Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)
# 8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, mode of operation, and intended use of the MStim Drop Model: LGT-233 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------|
| Device Name<br>and Model | MStim Drop Model: LGT-<br>233 | L300 Go System | MyGait Stimulation<br>System | -- | |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| 510 (K)<br>Number | Applying | K162407 | K141812 | -- | |
| Product Code | GZI, IPF | GZI, IPF | GZI, IPF | -- | |
| Regulation<br>Number | 882.5810, 890.5850 | 21 CFR § 882.5810<br><br>21 CFR § 890.5850 | 21 CFR 882.5810, 21 CFR § 890.5850 | -- | |
| Indication for<br>use | The MStim Drop LGT-233 is<br>intended to provide ankle<br>dorsiflexion in individuals who<br>have a dropped foot as a<br>consequence of upper motor<br>neuron injury. The device<br>electrically stimulates muscles<br>in the affected leg to provide<br>ankle dorsiflexion of the foot<br>and/or knee flexion or<br>extension; thus, it also may<br>improve the individual's gait.<br><br>The MStim Drop LGT-233<br>may also:<br><br>Prevent/retard disuse<br>atrophy<br><br>Maintain or increase joint<br>range of motion<br><br>Increase local blood flow | The L300 Go System is<br>intended to provide ankle<br>dorsiflexion in adult and<br>pediatric individuals with<br>foot drop and/or assist<br>knee flexion or extension<br>in adult individuals with<br>muscle w eakness related<br>to upper motor neuron<br>disease/injury (e.g.,<br>stroke, damage to<br>pathways to the spinal<br>cord). The L300 Go<br>Systemelectrically<br>stimulates muscles in the<br>affected leg to provide<br>ankle dorsiflexion of the<br>foot and/or knee flexion or<br>extension; thus, it also<br>may improve the<br>individual's gait. | The stimulation system is<br>intended to provide ankle<br>dorsiflexion and knee flexion<br>or extension in individuals with<br>foot drop and thigh muscle<br>weakness following an upper<br>motor neuron injury or<br>disease.<br><br>During gait, the stimulation<br>system sends electric stimuli<br>to muscles in the affected leg,<br>initiating dorsiflexion of the foot<br><br>and knee extension or flexion<br>and may thus improve the<br>individual's gait. The<br>stimulation system may also<br>prevent or retard atrophy<br>caused by inactivity, facilitate<br>muscle reeducation, maintain<br>or improve the range of motion<br>in the joints and promote local<br>blood circulation. | SE | |
| Apply parts | Leg | Leg and foot | Leg and foot | SE | |
| Power Sources | Adapter model: HYI11-005<br>(USA) and HYI11-005<br>(Europe)<br><br>Adapter supply voltage: AC<br>100~240V, 50/60Hz<br><br>Adapter output: DC 5V, 2A<br><br>Battery: 3.7V, 1200mAh,<br>lithium battery. | Battery operated | Battery operated | Minor<br>difference<br>Note 1 | |
| Indicator<br>display | LED and APP | -- | -- | Minor<br>difference<br>Note 1 | |
| Elements of<br>Compariso<br>n | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Method of Line<br>Current<br>Isolation | Battery operated | -- | Medical Class II Power<br>Adapter | SE | |
| Number of<br>Modes for<br>Micro current<br>stimulation | 2<br>(For Evaluation mode: no<br>micro current stimulation) | Two modes: Biphasic<br>Symmetric and Biphasic<br>Asymmetric.<br>Applicable to both lower<br>leg and thigh position of<br>the device. | 2 | SE | |
| Number of<br>Channels for<br>Micro current<br>stimulation | 1 | Lower leg small cuff<br>- 1 channel;<br>Lower leg regular<br>cuff - 1 or 2 channels (in 2<br>channel configuration,<br>both<br>channels function as a<br>single channel with<br>separately adjustable<br>medial / lateral stimulation<br>intensity);<br>Thigh cuff - 1 channel | 2 | SE | |
| Synchronous<br>or Alternating | Not applicable – single<br>channel device | Alternating (at one time<br>only one channel is<br>activated) | Synchronous or alternating | SE | |
| Regulated<br>Current or<br>Regulated<br>Voltage | Regulated Voltage | Current | Regulated Current | SE<br>Note 2 | |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Software/Firmware/<br>Microprocessor<br>control | Yes | Yes | Yes | SE | |
| Automatic Overload<br>Trip | Yes | Yes | Yes | SE | |
| Automatic No-load<br>Trip | Yes. | Yes | Yes | SE | |
| Automatic Shut Off | Yes. | Yes | No | SE | |
| Patient Override<br>Control | Yes | Yes | Yes<br>ON/OFF Button | SE | |
| Indic<br>ator<br>Displ<br>ay | On/Off<br>Status | Yes | Yes | Yes | SE |
| | Low<br>Battery | Yes | Yes | Yes | SE |
| | Voltag<br>e/Curr ent<br>Level | Yes | Yes | No | SE |
| Timer Range | | Treatment time: 1min-<br>60min, stepping 1min;<br>Timer tolerance: ±2%;<br>When finish, the device<br>can stop output and<br>prompt | Max<br>stimulation<br>duration (clinician<br>selectable)<br>Training mode: 5-60<br>minutes | 5 to 120min in steps of<br>5 min | Minor difference<br>Note 2 |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Console weight | 60g (only main unit) | Control Unit: 60g, EPG:<br>60g, Lower leg FSC:150g,<br>Thigh cuff: 300g, Foot<br>Sensor: 25g | 78g | SE | |
| Housing<br>Materials and<br>Construction | ABS | Remote Control:<br>Bay State Polymer<br>PA-2000RX<br><br>EPG: Bay State Polymer<br>PA-2000RX<br>(Polycarbonate + ABS)<br>Lower Leg FSC:<br>Biocompatible fabric over<br>plastic (POM Hi) skeleton<br><br>Thigh FSC: TPU Foot<br>Sensor: ABS (Sensor<br>housing), Bay state<br>Polymer<br>PA-2000RX (Electronics<br>housing) | ABS | SE | |
| Waveform | Biphasic square | Biphasic Symmetrical | Biphasic | SE | |
| Shape | Rectangular | Rectangular | Rectangular | SE | |
| Maximum<br>Output Voltage<br>(+/- 10%) | 50V ±10% @ 500Ω<br>90V ±10% @ 1KΩ<br>120V ±10% @ 2KΩ<br>130V ±10% @ 10KΩ | Lower leg: 50V@500Ω<br>Thigh: 50V@500Ω<br><br>Lower leg: 130V@2K Ω<br>Thigh: 130V@2K Ω<br>lower leg: 130V@10K Ω<br>Thigh: 130V@10K Ω | 45V +-10% @ 500Ω<br>90V +-10% @ 1KΩ<br>120V +-10%@2K Ω<br>n/a @10K Ω<br>(no stimulation possible at<br>10kΩ) | Minor difference<br>Note 3 | |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Maximum<br>output Current | 100mA ±10% @ 500Ω<br>90mA ±10% @ 1KΩ<br>60mA ±10% @ 2KΩ<br>13mA ±10% @ 10KΩ | Lower leg: 100mA@500Ω<br>Thigh: 100mA@500Ω<br>Lower leg: 65mA@2KΩ<br>Thigh: 65mA@2KΩ<br>Lower leg: 13mA@10KΩ<br>Thigh: 13mA@10KΩ | 90mA (+/- 10%) @ 500Ω<br>90mA (+/- 10%) @ 1KΩ<br>60mA (+/- 10%)@ 2K Ω<br>n/a @10K Ω<br>(no stimulation possible at<br>10KΩ) | Minor difference<br>Note 3 | |
| Frequency<br>range | 10~80Hz | 10, 15, 20, 25, 30, 35, 40,<br>45 Hz…
