Portable Electro-Stimulation Therapy Device

K182020 · Guangzhou Longest Science & Technology Co., Ltd. · NGX · Sep 17, 2020 · Physical Medicine

Device Facts

• Record ID: K182020
• Device Name: Portable Electro-Stimulation Therapy Device
• Applicant: Guangzhou Longest Science & Technology Co., Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Sep 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES, TENS. NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance. TENS is used to: 1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. 2. Symptomatic relief and management of chronic, intractable pain associated with arthritis.

Device Story

Portable Electro-Stimulation Therapy Device (LGT-231) is a dual-channel, battery-powered stimulator delivering electrical current to nerves and muscles via skin-applied electrodes. System comprises a main unit and 'MStim Reha' mobile app. User selects output mode (NMES or TENS), frequency, pulse width, and treatment time via app; main unit adjusts intensity and power. TENS mode targets sensory nerves to modify pain perception; NMES mode targets motor nerves to induce muscle contraction for training/recovery. Used by adults in home or clinical settings. Output parameters (pulse frequency, duration) determine muscle work type. Device provides non-invasive pain management and muscle performance improvement.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety, electromagnetic compatibility (EMC), biocompatibility, and software verification/validation.

Technological Characteristics

Dual-channel, battery-powered (rechargeable lithium) stimulator. Materials: PC+ABS casing, PMMA button panel, ABS buttons. Waveforms: Symmetrical biphasic (NMES/TENS). Connectivity: Bluetooth 4.0 for mobile app control. Standards: ANSI AAMI ES60601-1, IEC 60601-2-10, ISO 10993-5/10, ANSI AAMI ES60601-1-11. Software-controlled intensity and mode selection.

Indications for Use

Indicated for adults for NMES (stimulate healthy muscles to improve/facilitate performance) and TENS (temporary relief of pain from exercise/household/work strain; symptomatic relief/management of chronic, intractable pain and arthritis-associated pain).

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

• Compex Sport Elite (K170918)

Submission Summary (Full Text)

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September 17, 2020

Guangzhou Longest Science & Technology Co., Ltd. % You Yiiie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, 510663 Cn

Re: K182020

Trade/Device Name: Portable Electro-Stimulation Therapy Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: July 27, 2020 Received: July 27, 2020

Dear You Yijie:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182020

Device Name

Portable Electro-Stimulation Therapy Device, model LGT-231

Indications for Use (Describe)

Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES, TENS.

NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.

TENS is used to:

1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

2. Symptomatic relief and management of chronic, intractable pain associated with arthritis.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary

## 1. Submitter's Information

#### Establishment Registration Information

Name: Guangzhou Longest Science & Technology Co., Ltd. Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone, Guangzhou, Guangdong CHINA

# Contact Person of applicant

Name: Xiaobing Luo Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone Guangzhou, Guangdong CHINA TEL: [phone] FAX: [phone] Email: [e-mail]

## Contact Person of the Submission:

Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail]

## Contact Person to prepare summary:

Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail] Date to prepare: 7/5/2018

# 2. Device Information

Type of 510(K) submission: Traditional Trade Name: Portable Electro-Stimulation Therapy Device Model: LGT-231 Requlation name: Powered muscle stimulator. Transcutaneous electrical nerve stimulator for pain relief. Review panel: Physical Medicine, Neurology Product code: NGX, NUH, NYN Regulation Class: II Regulation Number: 21 CFR 890.5850, 21 CFR 882.5890

# 3. Predicate Device Information

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| 510(k) submitter/holder: | DJO, LLC |
|--------------------------|----------------------------------------------------------------------------------------|
| 510(K) Number: | K170918 |
| Device: | Compex Sport Elite |
| Trade name: | Compex Sport Elite |
| Regulation name: | Powered muscle stimulator. Transcutaneous electrical nerve stimulator for pain relief. |
| Review panel: | Physical Medicine, Neurology |
| Product code: | NGX, NUH, NYN |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 890.5850, 21 CFR 882.5890 |

## 4. Device description

The Portable Electro-Stimulation Therapy Device, model LGT-231 is a dual channel stimulator which sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Reha, main unit and electrodes.

The Mobile App MStim Reha provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible device for selecting a pre-programmed output mode, adjusting frequency, pulse width and treatment time. Software operating environment of Mobile App MStim Reha are Android 4.3 or later mobile phone, with 4.0 Bluetooth and iOS 8.0 or later iPhone mobile phone, with 4.0 Bluetooth. Click the MStim Reha Application installation package on the phone to install the application. MStim Reha Application and the device can be connected via Bluetooth.

The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.

The two modes that Portable Electro-Stimulation Therapy Device, model LGT-231 employs are neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). Neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS) target different nerve groups of the body.

TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Self-adhesive electrodes are placed on the skin close to the area of pain.

NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training: warming up or recovering. The Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Portable Electro-Stimulation Therapy Device may

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therefore be considered a technique of muscle training.

# 5. Principle of operation:

The Portable Electro-Stimulation Therapy Device, model LGT-231 sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin and powered by rechargeable lithium battery. When used in TENS mode, it is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain; and it uses tiny electrical impulses sent through the skin to nerves to modify the pain perception and finally helps control the pain. IN NMES mode. Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrodes, the electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response and to create a muscle contraction to recruit more muscle fibers when training.

# 6. Indications for Use

Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES and TENS.

NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.

TENS is used to:

1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

2. Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

# 7. Summary of technological characteristics of device compared to the predicate devices (K170918)

| Characteristic | Subject device<br>Present application<br>(Portable<br>Electro-Stimulation<br>Therapy Device, model<br>LGT-231) | Predicate device<br>(K170918, Compex<br>Sport Elite) | Discussion of difference | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Guangzhou Longest<br>Science & Technology<br>Co., Ltd | DJO, LLC | / | |
| Picture | Image: Portable Electro-Stimulation Therapy Device, model LGT-231 | Image: Compex Sport Elite | / | |
| Classification | | 21 CFR 890.5850,<br>21 CFR 882.5890 | 21 CFR 890.5850,<br>21 CFR 882.5890 | Same |
| Prescription/OTC | | OTC | OTC | Same |
| Product Code | | NGX, NUH, NYN | NGX, NUH, NYN | Same |
| FDA Class | | II | II | Same |
| Intended Use | | Portable<br>Electro-Stimulation<br>Therapy Device, model<br>LGT-231 is to be used by<br>adults only and has two<br>modes NMES and TENS.<br><br>NMES is used to: stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance.<br><br>TENS is used to:<br>1. Temporary relief of pain<br>associated with sore and<br>aching muscles due to<br>strain from exercise or<br>normal household and<br>work activities.<br>2. Symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis. | NMES: The Compex Sport<br>Elite is intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance. The work<br>imposed on the muscles by<br>the Compex Sport Elite<br>programs is not suitable for<br>rehabilitation or<br>physiotherapy.<br><br>TENS: The Compex Sport<br>Elite TENS is intended for:<br>• Temporary relief of pain<br>associated with sore and<br>aching muscles due to<br>strain from exercise or<br>normal household and<br>work activities<br>• They symptomatic relief<br>and management of<br>chronic, intractable pain<br>and relief of pain<br>associated with arthritis.<br><br>The Compex® Sport Elite<br>is an Over-The-Counter<br>device to be used by adults<br>only. | Same |
| target population | | adults | adults | Same |
| Power Source | | Rechargeable lithium<br>battery 3.7V | Rechargeable Ni-Mh<br>Battery 4.8V | Similar<br>The proposed device was<br>demonstrated electromagnetic<br>compatility and electrical safety<br>by the testing. The difference<br>does not raise the issue of<br>product's safety and<br>effectiveness. |
| Method of line<br>current isolation | | N/A (battery operated<br>device) | N/A (battery operated<br>device) | Same |
| Patient<br>Leakage<br>Current | Normal<br>condition | N/A (battery operated<br>device) | N/A (battery operated<br>device) | Similar<br>The proposed device was<br>demonstrated electrical safety by<br>passing ANSI AAMI ES60601-1<br>and IEC 60601-2-10 tests. The<br>difference does not raise the<br>issue of product's safety and<br>effectiveness. |
| | Single fault<br>condition | N/A (battery operated<br>device) | N/A (battery operated<br>device) | Same |
| Number<br>of Output<br>Channels | Number | Two | Four | Different |
| | | | | More channels means it can be<br>applied on more different body<br>sides at the same time, and all<br>output channel works<br>independently from each other,<br>the proposed device has less<br>channels than equivalent device,<br>this can be addressed by applied<br>two proposed device, therefore,<br>the different channel number will<br>not affect the safety and<br>effectiveness of the proposed<br>device. |
| Synchronous<br>or<br>Alternating? | | Synchronous | Synchronous | Same |
| Method of<br>Channel<br>Isolation | | Isolating transformer | Each channel is the middle<br>of a H-Bridge. Except when<br>it is activated, each<br>channel is always in high<br>impedance state. | Similar<br>The proposed device was<br>demonstrated electrical safety by<br>passing ANSI AAMI ES60601-1<br>and IEC 60601-2-10 tests. The<br>difference in Method of Channel<br>Isolation does not raise the issue<br>of product's safety and<br>effectiveness. |
| Number of Output<br>Modes | | Two (TENS and NMES) | two (TENS and NMES) | Same |
| Regulated Current or<br>Regulated Voltage? | | Current | Current | Same |
| Software/Firmware/Micropr<br>ocessor Control? | | Yes | Yes | Same |
| Automatic Overload Trip? | | Yes | Yes | Same |
| Automatic No-Load<br>Trip? | | Yes | Yes | Same |
| Automatic Shut Off? | | "On/Off" button | "On/Off" switch | Same |
| User Override Control? | | Yes | Yes | Same |
| Indicator | On/Off Status? | Yes | Yes | Same |
| Display | Low Battery? | Yes | Yes | Same |
| | Voltage/ Current<br>Level? | Yes (on app) | Yes | Same<br>System validation<br>testing scenarios<br>covering mitigation of<br>wireless risks in<br>accordance with<br>RED were added to our full<br>system testing protocol to ensure<br>safe and effective use. |
| Timer Range<br>(minutes) | | Maximum = 60 minute | Maximum = 55 minute | Different<br>The treatment time is adjusted by<br>the user or depend on selected<br>programs, so the difference doesn't<br>affect the safety and effectiveness<br>of the proposed device. |
| | Compliance with 21 CFR<br>898? | Yes | Yes | Same |
| | ANSI AAMI ES60601-1 | Yes | Yes | Same |
| IEC 60601-2-10 | Yes | Yes | Same | |
| Weight | 120g (only main unit) | 300 g | Different<br>The Weight will not affect the<br>safety and effectiveness of the<br>proposed device | |
| Dimensions (mm)<br>(W x H x D) | 62 (W) × 122 (L) × 27 (H)<br>(mm) | 99 x 142 x 36 (mm)<br>3.9 x 5.6 x 1.4 (in) | Different<br>The dimensions will not affect the<br>safety and effectiveness of the<br>proposed device | |
| Housing Materials and<br>Construction | Casing: Plastic (PC+ABS,<br>with PMMA on the button<br>panel)<br>Buttons: ABS<br>Light pipe: PC | Casing:<br>Plastic (ABS, with PMMA<br>on the windows)<br>Buttons:<br>Silicon, rubber<br>Battery Pack:<br>Rigid, ABS housing<br>around the battery<br>cells<br>Battery contacts:<br>SK5 steel | Similar<br>The Housing Materials and<br>Construction form the basic<br>construction and ensure the basic<br>safety of device, since the<br>proposed device was<br>demonstrated electrical safety by<br>passing ANSI AAMI ES60601-1<br>and IEC 60601-2-10 tests, the<br>existed difference will not affect<br>the safety of the proposed device. | |
| Programs | NMES:<br>TENS:<br>- Normal<br>- Sweep<br>- Random<br>- Alternation represents<br>different frequency<br>modulation methods) | NMES:<br>- Endurance<br>- Resistance<br>- Strength<br>- Explosive Strength<br>- Potentiation<br>- Training Recovery<br>(same as Active<br>Recovery)<br>- Competition<br>Recovery (same as<br>Recovery Plus)<br>- Pre-Warmup<br>Program<br>- Muscle Relaxation<br>(same as Massage)<br>TENS:<br>-Pain relief TENS<br>(same as FM) | Similar<br>The two devices have two same<br>main Output Modes: NMES and<br>TENS, both modes NMES and<br>TENS of these two devices also<br>have same indications<br>respectively, although both<br>modes have different output<br>programs, these two modes have<br>almost the same parameter<br>range, and the NMES of the<br>proposed device can be adjusted<br>arbitrarily within the parameter<br>range, the TENS output<br>programs: Normal, Sweep,<br>Random, Alternation represents<br>different frequency…