GYMFORM ABS & CORE

K142055 · Well Brain International , Ltd. · NGX · May 11, 2015 · Physical Medicine

Device Facts

• Record ID: K142055
• Device Name: GYMFORM ABS & CORE
• Applicant: Well Brain International , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: May 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.

Device Story

Battery-operated (2x AAA) powered muscle stimulator; console generates electrical signals delivered via replaceable electrode pads on belts. User-controlled intensity and mode via console buttons. Used by patients for muscle training on abdomen, lower back, arms, legs, thighs, or buttocks. Device provides alternating electrical current to targeted muscle groups; output parameters (frequency, pulse width, intensity) adjustable. Healthcare provider/user monitors output via console display. Benefits include improved muscle performance through electrical stimulation.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), software verification/validation, waveform output verification, accelerated aging (ASTM F 1980-07), and electrode adhesion (AAMI EC 12:2000).

Technological Characteristics

Powered muscle stimulator; 2-channel; battery-powered (2x 1.5V AAA). Console (ABS plastic), belts (polyester), electrode pads (glycerine, polyacrylic acid, water, salt). Symmetrical rectangular waveform. Output: 2-120 Hz, 31 intensity steps. Connectivity: None. Sterilization: Not applicable. Software: Microprocessor-controlled, non-adaptive.

Indications for Use

Indicated for stimulation of healthy muscles in adults to improve or facilitate muscle performance. Intended for use on abdomen, lower back, arms, legs, thighs, or buttocks. Contraindications not specified.

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

• Gymform® ABS-A-ROUND, model: VDPGYCIND0016 (K130074)
• Contour Technology Muscle Stimulator (K111476)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 11, 2015

Well Brain International, Ltd. Victor K. Wai Managing Director Room 03, 14/F, Fook Yip Bldg. 53-57 Kwai Fung Crescent Kwai Chung, N. T. Hong Kong, China

Re: K142055

Trade/Device Name: GYMFORM® ABS&CORE, Model: VDPGYCSET0042 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 3, 2015 Received: April 10, 2015

Dear Mr. Wai.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Felipe Aquel -S

Carlos L. Peña, PhD, MS for 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) K142055

Device Name GYMFORM® ABS&CORE, Model: VDPGYCSET0042

Indications for Use (Describe)

GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.

| 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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Sponsor: Well Brain International Ltd. Subject Device: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 File No.: 510(k) submission report (V1.0), Chapter 5

### Chapter 5. 510(k) Summary

## 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

### 1. Date of the summary prepared: May 8, 2015

#### 2. Submitter's Information

- 510(k) Owner's Name: Well Brain International Ltd. �
- � Establishment Registration Number: 3004950644
- � Address: Room 03, 14/F, Fook Yip Bldg., 53-57 Kwai Fung Crescent, Kwai Chung, N. T. Hong Kong, China
- � Phone: [phone]
- � Fax: [phone]
- � Contact Person: Victor K Wai
- Email: [e-mail] �

#### 3. Subject Device Information

- GYMFORM®ABS & CORE, Model: VDPGYCSET0042 � Trade Name:
- Powered muscle stimulator Common Name: �
- Stimulator, Muscle, Powered, For muscle conditioning � Classification name:
- Physical Medicine Review Panel: �
- NGX Product Code: �
- ll Regulation Class: �
- 890:5850 � Regulation Number:

#### 4. Predicate Device Information

| Predicate<br>Device | Predicate Device I | Predicate Device II |
|---------------------|-------------------------------|---------------------|
| Sponsor | Well Brain International Ltd. | Contour Technology |

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| Predicate<br>Device | Predicate Device I | Predicate Device II |
|----------------------|-----------------------------------------------|-----------------------------------------|
| Device Name | Gymform® ABS-A-ROUND,<br>model: VDPGYCIND0016 | Contour Technology<br>Muscle Stimulator |
| 510(k) Number | K130074 | K111476 |
| Product Code | NGX | NGX |
| Regulation<br>Number | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Regulation<br>Class | II | II |

### 5. Device Description

GYMFORM® ABS&CORE is a two channels battery operated muscle stimulation system specifically designed to stimulation the muscles.

The 2-area belt is intended for use on the muscles in abdomen or lower back separately.

Mini belt is intended for use on the muscles in arms, legs, thighs and buttocks areas separately.

It is comprised of a console for signal generation, two belts (2-area belt and mini belt) for fixation, and electrode pads for signal connection to skin. The electrode pads are replaceable.

Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.

The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the device are controlled by the buttons. Its intensity level can be adjustable by user.

### 6. Intended Use / Indications for Use

GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.

### 7. Test Summary

ABS & CORE has been evaluated the safety and performance by lab bench testing as following:

- Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards �

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- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- � Waveform test report to verify the output specifications of the device according to IEC 60601-2-10 and Guidance for Powered Muscle Stimulator.
- � Dispersion test and Shelf test according to ASTM F 1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devicesand Guidance: Shelf Life of Medical Device.
- � Adhesion test according to Section 5.4 of AAMI EC 12_2000_(R) 2010 Disposable ECG electrodes.

#### Comparison to predicate device and conclusion 8.

The technological characteristics, features, specifications, materials, mode of operation, and intended use of GYMFORM®ABS & CORE is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements<br>of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| Basic Unit Characteristics | | | | | |
| Device Name and<br>Model | GYMFORM® ABS &<br>CORE, Model:<br>VDPGYCSET0042 | Gymform®<br>ABS-A-ROUND,<br>model:<br>VDPGYCIND0016 | Contour Technology<br>Muscle Stimulator | -- | |
| 510 (K) Number | Applying | K130074 | K111476 | -- | |
| Intended Use | GYMFORM®ABS&<br>CORE is intended to<br>stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle<br>performance. The<br>ABS& CORE may<br>be considered a<br>technique or method<br>for muscle training. | Intended Use /<br>Indications for Use:<br>The<br>GYMFORM®ABS-A<br>-ROUND is<br>intended to<br>stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle<br>performance. The<br>ABS-A-ROUND | The Contour<br>Technology Muscle<br>Stimulator is<br>intended to stimulate<br>healthy muscles in<br>order to improve or<br>facilitate muscle<br>performance. The<br>Contour Technology<br>Muscle Stimulator<br>may therefore be<br>considered a | SE | |
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| | intended for use on<br>the muscles in<br>abdomen or lower<br>back separately.<br>Mini belt is intended<br>for use on the<br>muscles in arms,<br>legs, thighs or<br>buttocks areas<br>separately. | may be considered<br>a technique or<br>method for muscle<br>training.<br>The 3-area belt is<br>intended for use on<br>the muscles in<br>abdomen, left waist<br>and right waist<br>alternately.<br>The Mini belt is<br>intended for use on<br>the muscles in<br>arms, legs (lower<br>extremities), thighs<br>and buttocks areas<br>separately. | technique or method<br>for muscle training.<br>The Contour<br>Technology Muscle<br>Stimulator Ab Belt<br>accessory is<br>intended for use on<br>abdominal muscles<br>only for<br>strengthening and<br>toning of abdominal<br>muscles.<br>The Contour<br>Technology Muscle<br>Stimulator BackPad<br>accessory is<br>intended for use on<br>the lower back<br>muscles only. | | |
| Stimulated muscles | Abdomen, lower<br>back, arms, legs,<br>thighs and buttocks | Abdomen, lower<br>back, arms, legs,<br>thighs and buttocks | Abdomen, lower<br>back | SE | |
| Power Sources | 2 x 1.5V AAA<br>batteries | 3 x 1.5V AAA<br>batteries | 4 x 1.5V AAA<br>batteries | SE<br>Note 1 | |
| Method of Line<br>Current Isolation | Battery Supply N/A | Battery Supply N/A | Battery Supply N/A | SE | |
| Patient<br>Leakage<br>Current | Normal<br>Condition | 10μA | 5.8μA | -- | SE<br>Note 1 |
| | Single<br>Fault<br>Condition | 50μA | 8.5μA | -- | SE<br>Note 1 |
| Number of Modes | | 6 | 6 | -- | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Number of Channels | 2 | 3 | -- | SE<br>Note 1 | |
| -Synchronous or<br>Alternating | Alternating | Alternating | -- | SE | |
| -Method of Channel<br>Isolation | Press MODE button<br>for 3 seconds | Press FLR button | -- | SE<br>Note 1 | |
| Number Intensity<br>Level | 31 steps | 99 steps | -- | SE<br>Note 1 | |
| Regulated Current or<br>Regulated Voltage | Regulated Voltage | Regulated Voltage | -- | SE | |
| Software/Firmware/Mi<br>croprocessor control | Yes | Yes | -- | SE | |
| Automatic Overload<br>Trip | No | No | -- | SE | |
| Automatic No-load<br>Trip | Yes. | Yes. | -- | SE | |
| Automatic Shut Off | Yes. | Yes | -- | SE | |
| Patient Override<br>Control | Yes | Yes | -- | SE | |
| Indicator On/Off Status | Yes | Yes | -- | SE | |
| Indicator Low Battery | Yes | Yes | -- | SE | |
| Display Voltage/Current Level | Yes | No | -- | SE | |
| Timer Range | Default time is 10<br>minutes | Default time is 19<br>minutes | -- | SE<br>Note 1 | |
| Console weight | 50g(Without<br>batteries) | 70g (Without<br>batteries) | -- | SE<br>Note 1 | |
| Accessories weight | Big belt: 150g<br>Small belt: 65g<br>Electrode pad: 15g<br>Carry bag: 60g | 3-area belt: 310g<br>Mini belt: 25g<br>Electrode pad (big):<br>40g<br>Electrode pad | -- | SE<br>Note 1 | |
| Elements<br>of | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Comparison | | | | | |
| | | (small): 26g | | | |
| Console dimensions | 100 mm(L) x 68 mm<br>(W) x 24.5 mm (H) | 91.8 mm(L) x 25.5 mm (W) x82 mm (H) | -- | SE<br>Note 1 | |
| Electrode<br>pad<br>dimension | 40 mm (L) x 70 mm<br>(W) x 3mm (H) | Small: 33.0 cm²<br>Big: 34.5 cm² | 40.5 cm² | SE<br>Note 1 | |
| Housing<br>Materials<br>and Construction | Console: ABS plastic<br>Belt: Polyester<br>Electrode pads:<br>Glycerine,<br>Polyacrylic acid,<br>Water and Salt | Console: ABS plastic<br>Belt: Polyester<br>Electrode pads:<br>Glycerine,<br>Polyacrylic acid,<br>Water and Salt | -- | SE | |
| Output Specification | | | | | |
| Waveform | Symmetrical | Symmetrical | -- | SE | |
| Shape | Rectangular | Rectangular | -- | SE | |
| Maximum Output<br>Voltage(Vpeak-topeak)<br>(+/- 10%) | 132V @ 500Ω<br>138V @ 2kΩ<br>140V @ 10kΩ | 108V @ 500Ω<br>124V @ 2kΩ<br>126V @ 10kΩ | -- | SE<br>Note 2 | |
| Maximum Current<br>Density(Ipeak-topeak) | 264mA @ 500Ω<br>69mA @ 2kΩ<br>14mA @ 10kΩ | 216mA @ 500Ω<br>62mA @ 2kΩ<br>12.6mA @ 10kΩ | -- | SE<br>Note 2 | |
| Frequency range | 2 Hz, 10 Hz, 50 Hz,<br>90 Hz, 120 Hz | 2 Hz, 10 Hz, 50 Hz,<br>90 Hz, 120 Hz | 1 to 120 Hz | SE<br>Note 2 | |
| Pulse width range | 108μs / 124μs | 100 μs / 120 μs | -- | SE<br>Note 2 | |
| Elements<br>of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Pulse duration(Only<br>changes with the<br>mode) | Mode 1: 500ms;<br>Mode 2: 11.1ms;<br>Mode 3: 8.3ms;<br>Mode 4:<br>Front 90s: 11.1ms;<br>Back 90s: 8.3ms;<br>Mode 5: 100ms;<br>Mode 6: 20ms | Mode 1: 500ms;<br>Mode 2: 11.1ms;<br>Mode 3: 8.33ms;<br>Mode 4:<br>Front 90s: 11.1ms;<br>Back 90s: 8.33ms;<br>Mode 5: 100ms;<br>Mode 6: 20ms | 340 µs | SE<br>Note 2 | |
| Phase duration(Only<br>changes with the<br>mode) | Mode 1: Not<br>applicable(Continuo<br>us pulse)<br>Mode 2: 2s<br>Mode 3: 2s<br>Mode 4: 2s<br>Mode 5: 10s<br>Mode 6: 16s | Mode 1: Not<br>applicable(Continuo<br>us pulse)<br>Mode 2: 2s<br>Mode 3: 2s<br>Mode 4: 2s<br>Mode 5: 10s<br>Mode 6: 16s | -- | SE | |
| Net Charge | 19.2µC@ 500Ω | 15.7µC @ 500Ω | -- | SE<br>Note 2 | |
| Maximum Phase<br>Charge | 16.4µC@ 500Ω | 13.0µC@ 500Ω | -- | SE<br>Note 2 | |
| Maximum Current<br>Density | 0.082 mA/cm²@<br>500Ω | 0.057 mA/cm²@<br>500Ω | 0.55 mA/cm² @<br>500Ω | SE<br>Note 2 | |
| Maximum Power<br>Density | 94.8 μW/cm² @<br>500Ω | 53.8 μW/cm² @<br>500Ω | -- | SE<br>Note 2 | |
| ON time | 0.5s | 1s | -- | SE<br>Note 2 | |
| OFF time | 0.5s | 1s | -- | SE<br>Note 2 | |
| Contraction<br>and<br>Relaxation time | Adjustable, due to<br>different modes. | Adjustable, due to<br>different modes. | -- | SE | |
| Burst Mode | | | | | |
| Pulse per burst | 1~397 | 1~397 | -- | SE | |
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Bursts per second | 0.125~1 | 0.125~1 | -- | SE | |
| Burst Duration(s) | 1~8 | 1~8 | -- | SE | |
| Duty Cycle | 0.02%~1.28% | 0.02%~1.19% | -- | SE<br>Note 2 | |
| Additional Features | | | | | |
| Environment for operating | Temperature: 5 ~ 40°C<br>Humidity: 20 ~65% RH | Temperature: 5 ~ 45°C<br>Humidity: 20 ~65% RH | -- | SE | |
| | | | | | |
| | | | | | |
| Environment for storage | Temperature: 0~40° C<br>Humidity: 10 ~90% RH | Temperature: 5 ~ 45°C<br>Humidity: 20 ~65% RH | -- | SE | |
| | | | | | |
| | | | | | |
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE | |
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