Electrical Stimulator System

K232439 · Gymmax Technology Shenzen Co., Ltd. · NUH · Mar 21, 2024 · Neurology

Device Facts

• Record ID: K232439
• Device Name: Electrical Stimulator System
• Applicant: Gymmax Technology Shenzen Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Mar 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS (TENS 1 and TENS 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PMS (STIM1 STIM2 STIM3 and STIM4) To stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

Electrical Stimulator System delivers electrical pulses to body areas (shoulder, waist, back, arm, leg) via electrodes. Device features TENS and PMS (EMS) modes. User operates via M button, intensity increase/decrease buttons. Device is portable, compact, and intended for OTC use. Principle of operation: EMS pulses cause passive muscle contraction/flexion; TENS pulses block pain signals. Output affects muscle performance or provides temporary pain relief. System includes control unit, belt, USB cable, belt extension, and storage pouch.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and functional performance testing (output waveforms, stimulation parameters).

Technological Characteristics

Materials: ABS+PC housing. Sensing/Actuation: Biphasic symmetrical electrical pulses. Energy: Rechargeable battery. Form factor: Portable (75x55x13.8 mm). Connectivity: Standalone. Sterilization: Not specified. Software: Microprocessor-controlled, Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, arm, and leg due to exercise or normal household/work activities (TENS); and stimulation of healthy muscles to improve/facilitate muscle performance (PMS).

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1 (K171803)
• Health Expert Electronic Stimulator, Model AST300C and AST-300D (K133929)
• OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) (K130802)

Submission Summary (Full Text)

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March 21, 2024

Electronic Pulse Stimulator % Salon Chen System Engineer IMD Medical & Drug Technology Services Institutions Room 308, Building 11, No. 23 Jinqu Road Wanjiang District, Dongguan City ShenZhen City, Guangdong Province 518117 China

Re: K232439

Trade/Device Name: Electrical Stimulator System Regulation Number: 21 CFR 882.5890; 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 20, 2024 Received: February 20, 2024

Dear Salon Chen:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Robert Kang -S

for Pamela Scott

Assistant 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) K232439

Device Name Electrical Stimulator System

## Indications for Use (Describe)

TENS (TENS 1 and TENS 2)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PMS (STIM1 STIM2 STIM3 and STIM4)

To stimulate healthy muscles in order to improve and facilitate muscle performance.

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

| <input type="checkbox"/> Prescription Use (Part 34 CFR 301 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (34 CFR 301 Subpart C) |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|

__ 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- K232439

#### 1. Submitter's Identification:

- Company Name: Gymmax Technology Shenzhen Co., Ltd. >
- ハ Establishment Registration Number: 3007689716
- ▲ Address:5F 4th Bldg., Heping Complex (4th Bldg. Huimingsheng Technology Park) Fuhai Subdistrict, Baoan District Shenzhen City, Guangdong Province 518103 P.R.C.
- A Phone: [phone]
- ♪ Fax: [phone]
- Contact Person (Title): Benson Wang (General Manager) A
- E-mail: [e-mail] ハ
- > Date of Preparation: Feb.19, 2024

#### 2. Name of the Device:

- Electrical Stimulator System A
- Models: GMX-007 and GMX-006 A
- 3. Common Name and Classification:
- Stimulator, Nerve, Transcutaneous, Over-The-Counter A

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- ♪ Classification Product Code: NUH, NGX
- > Regulation Number:21 CFR 882.5890
- > Class: Il

#### 4. Predicate Device Information1:

- ハ 510(k) Number: K171803
- > Predicate Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1
- Manufacturer: HivoxBiotek Inc. A
- This predicate has not been subject to a design-related recall A
- A No reference devices were used in this submission.
- 5. Predicate Device Information2:
- A 510(k) Number: K133929
- Predicate Device Name: Health Expert Electronic Stimulator, Model AST300Cand AST-300D A
- Manufacturer: Shenzhen OSTO Technology Company Limited A
- This predicate has not been subject to a design-related recall A
- A No reference devices were used in this submission.
- 6. Predicate Device Information3:

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- 510(k) Number: K130802 A
- Predicate Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) >
- > Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD
- This predicate has not been subject to a design-related recall A
- No reference devices were used in this submission. A
- 7. Application Correspondent
- A Company Name: IMD Medical & Drug technology service institutions
- Phone: [phone] A
- A Fax: [phone]
- Contact Person (Title): Salon Chen (System engineer) A
- A E-mail: [e-mail]
- Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, Guangdong Province, China A

#### 8. Device Description

The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase

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button, intensity decrease button, and can be attached and detached to electrodes.

The electrodes cleared include accessory electrodes, which may be packaged separately and/or together with the subject device.

The associated accessories include:

Belt * 1

Control Unit * 1

USB Charging Cable * 1

Belt Extension Kit * 1

Storage pouch * 1

#### 9. Indications for Use

#### TENS (TENS 1 and TENS 2)

To be used for temporary relief of pain associated with shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

#### PMS (STIM1、STIM2、STIM3 and STIM4)

To stimulate healthy muscles in order to improve and facilitate muscle performance.

#### 10. Comparison to the predicate device

Electrical stimulation is the technological princes and predicate device. In the EMS modes, electronic pulses are sent through electrode passively exercise the affected muscle receives this signal, it contracts and flexes naturally, as it would during physical

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exercise. And like with physical exercise, when the muscle relates and the cycle can start over again. In the TENS modes, the gentle electrical pulses were sent through electrode pass and into stir to block or shut out the brain from the source of the pain.

### Table 1: Technological Characteristics

| Elements of Comparison | Proposed Device | Predicate Device1<br>(K171803) | Predicate Device2<br>(K133929) | Predicate Device3<br>(K130802) | Judgment | | |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------|----------|
| Company Name | Gymmax Technology<br>Shenzhen Co., Ltd. | HIVOX BIOTEK INC. | Shenzhen OSTO<br>Technology Company<br>Limited | SHENZHEN DONGDIXIN<br>TECHNOLOGY CO, LTD | / | | |
| Device Name | Electrical Stimulator<br>System | HIVOX OTC Electrical<br>Stimulator/SEM44 | Health Expert Electronic<br>Stimulator, Model AST300C<br>and AST-300D | OTC ELECTRICAL STIMULATOR<br>(MT9001), OTC TENS DEVICE<br>(LT3060) | / | | |
| Classification Product Code | NUH | NUH | NUH | NUH | SE | | |
| Subsequent Product Codes | NGX | NGX | NGX | NGX | SE | | |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | SE | | |
| Classification Name | Transcutaneous electrical<br>nerve stimulator for pain<br>relief | Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | Transcutaneous electrical<br>nerve stimulator for pain<br>relief | Transcutaneous electrical nerve<br>stimulator for pain relief | SE | | |
| Class | 2 | 2 | 2 | 2 | SE | | |
| | Prescription or OTC | OTC | OTC | OTC | OTC | SE | |
| | Functions and design | Electrical stimulation | Electrical stimulation | Electrical stimulation | Electrical stimulation | SE | |
| | Power Source(s) | Rechargeable battery | 4.5V (batteries,<br>3×1.5V AAA) | Adaptor Input: 100- 240Vac,<br>50-60Hz, 0.1A Output: 5Vdc,<br>1A Unit Input: 5Vdc, 1A | 9V batteries | SE | |
| | Method of Line Current<br>Isolation | Type BF Applied Part | N/A | Type BF Applied Part | N/A | SE | |
| Patient<br>Leakage<br>Current | Normal condition | N/A | N/A | AC: 54.5μA, DC: 0.5μA | 0.61μA | SE | |
| | Single fault<br>condition | N/A | N/A | AC:120.0μA,<br>DC: 0.6μA | 0.68μA | SE | |
| | Number of Output Modes | TENS: 2<br>EMS: 4 | EMS: 35<br>TENS:15 | EMS: 8<br>TENS:17 | TENS: 1<br>EMS: 1 | SE<br>Note 3 | |
| | Number of Output Channels | 1 | 2 | 2 | N/A | SE<br>Note 3 | |
| | Synchronous<br>or<br>Alternating | N/A | Synchronous | Synchronous | Alternating | SE | |
| | Method of Channel Isolation | By electrical circuit and<br>software | By electrical circuit and<br>software | Voltage Transform Isolation<br>"BODY▼" and "BODY▼"<br>buttons for body channel,<br>"SOLE▲" and "SOLE▼"<br>buttons for feet channel | By electrical circuit and<br>software | SE | |
| | Regulated Current or<br>Regulated Voltage? | Current control | Regulated voltage | Current control | Current control | SE | |
| | Software/Firmware/Micropr<br>ocessor Control | Yes | Yes | Yes | Yes | SE | |
| | Automatic Overload Trip? | No | Yes | No | Yes | SE | |
| | Automatic No-Load Trip? | Yes | Yes | No | Yes | SE | |
| | Automatic Shut Off? | Yes | Yes | Yes | Yes | SE | |
| | Patient Override Control? | Yes | Yes | Yes | Yes | SE | |
| | On/Off Status? | Yes | Yes | Yes | Yes | SE | |
| Indicato<br>r Display | Low Battery? | Yes | Yes | Yes | Yes | SE | |
| | Voltage/Current<br>Level? | Yes | Yes | Yes | Yes | SE | |
| Timer Range (minutes) | 30minutes | 5~100minutes | 25 minutes | 1-60 minutes | SE<br>Note 3 | | |
| Weight | 40.6G [without pad] | 89g (including belt<br>clip,<br>without batteries)<br>123g (including belt<br>clip,<br>and batteries) | 2Kg (Without accessories) | 128g (including batteries) | SE<br>Note 4 | | |
| Dimensions (in.) [W x H x D] | 75*55*13.8 mm | 132 x 63 x<br>29.5mm (including<br>belt<br>clip) | 428mm x 428.8mm x<br>185mm | 117 x 60 x 34 mm | SE<br>Note 4 | | |
| Housing Materials and<br>Construction | ABS+PC | ABS | ABS | ABS | SE | | |
| Intended Use | TENS (TENS 1 and TENS<br>2)<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, arm, and leg,<br>due to strain from exercise<br>or normal household and<br>work activities. | SEM44 (EMS): The<br>device is designed to<br>be used for stimulate<br>healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance.<br>SEM44 (TENS): The<br>device is designed to<br>be used for temporary<br>relief of pain<br>associated with sore<br>and aching muscles in<br> | PMS (Mode 1~8) It is<br>intended to stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance. | MT9001 -<br>TENS: The device is designed to<br>be used for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, neck, upper extremities<br>(arm), and lower extremities (leg)<br>due to strain from exercise or<br>normal household work activities.<br>EMS: The device is designed to be<br>used for stimulate healthy muscles<br>in order to improve and facilitate<br>muscle performance. | SE<br>Note 1 | | |
| Intended Use | PMS (STIM1 、STIM2<br>STIM3 and STIM4)<br>To stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance. | SEM44-1 -<br>TENS: The device is<br>designed to be used<br>for temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm),<br>lower extremities<br>(leg), abdomen and<br>bottom due to strain<br>from exercise or<br>normal household<br>work activities. | TENS (Mode 9~25)<br>To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>back of the neck, arm, leg,<br>and foot due to strain from<br>exercise or normal<br>household work activities by<br>applying current to stimulate<br>nerve. | LT3060 -<br>TENS: The device is designed to<br>be used for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, neck, upper extremities<br>(arm), and lower extremities (leg)<br>due to strain from exercise or<br>normal household work activities. | SE<br>Note 1 | | |
| Safety factor & Performance | Proposed Device | Predicate Device1 | Predicate Device2 | Predicate Device3 | Judgment | | |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE | | |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE | | |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | SE | | |
| Performance | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | SE | | |
| Waveform | Biphasic, symmetrical | Biphasic, square | Pulsed, symmetric, Biphasic, Rectangular | Biphasic Square | SE | | |
| Burst Mode | Pulses per burst | 2 | 3 | -- | 7 | N/A | SE |
| | Bursts per second | 5 / 50Hz | 2/60Hz | -- | 0.5/1/2/3/4/5 Hz | N/A | SE |
| Burst Mode | Burst duration (seconds) | 20ms | 36ms | -- | 70ms | N/A | SE |
| | Duty<br>Cycle<br>[Line(b) x<br>Line (c)] | 20ms/100ms | 36ms/390ms | -- | 35ms/350ms | N/A | SE |
| ON Time (seconds) | | 0.25s~6.5s | 2s | 0.6s | N/A | 1-30 | SE |
| OFF Time (seconds) | | 0.25s~4.6s | 2s | 0.6s | N/A | 1-60 | SE |
| Maximum output<br>voltage (volts+/-20%)<br>at 500Ω | | TENS 1:112<br>TENS 2: 114<br>STIM1:116<br>STIM2:116<br>STIM3:76<br>STIM4: 70 | 100±10 % (50±10 %(Vp))…