Who is the manufacturer of GYMFORM ABS-A-ROUND?

Well Brain International , Ltd. filed the 510(k) submission for GYMFORM ABS-A-ROUND (K130074).

What is the FDA product code for GYMFORM ABS-A-ROUND?

NGX. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for GYMFORM ABS-A-ROUND?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GYMFORM ABS-A-ROUND?

X2ABS Dual Channel Fitness Belt (K102295); Gymform Dual Shape flex belt (K111781); Contour Technology Muscle Stimulator, Model: MX9 (K111476); Prospera OTC TENS Electronic Pulse Massager (K122744); Body Control System '4M' (K092476).

Who can help prepare an FDA 510(k) submission like GYMFORM ABS-A-ROUND?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GYMFORM ABS-A-ROUND

K130074 · Well Brain International , Ltd. · NGX · Aug 15, 2013 · Physical Medicine

Device Facts

Record ID	K130074
Device Name	GYMFORM ABS-A-ROUND
Applicant	Well Brain International , Ltd.
Product Code	NGX · Physical Medicine
Decision Date	Aug 15, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.

Device Story

Battery-operated, three-channel muscle stimulation system; includes electronic stimulator module, fixation belts, and replaceable skin-contact electrodes. Device delivers electrical current to targeted muscle groups; user-controlled via buttons to adjust intensity levels and mode programs. Operates in a pre-set sequence: F channel (180s), 10s idle; L channel (180s), 10s idle; R channel (180s), 10s idle; cycle repeats. Used by healthy individuals for muscle conditioning/training. Output parameters (intensity, mode) are displayed on an LCD. Benefits include improved muscle performance through electrical stimulation.

Clinical Evidence

Bench testing only. Compliance verified with electrical safety standards IEC 60601-1 and IEC 60601-2-10, and electromagnetic compatibility standard IEC 60601-1-2. Waveform testing performed to verify device parameters.

Technological Characteristics

Battery-powered (3 x 1.5V AAA) muscle stimulator. 3-channel output. Features LCD for power, channel, intensity, and mode status. Materials contacting skin comply with ISO 10993-5 and ISO 10993-10. Output: 0-118V (0-1000 Ohm). Frequency range: 2, 10, 50, 90, 120 Hz. Pulse width: 100/120 us. Operates via pre-programmed stimulation sequences.

Indications for Use

Indicated for healthy individuals to stimulate muscles in the abdomen, waist, arms, legs, thighs, and buttocks to improve or facilitate muscle performance and training.

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

X2ABS Dual Channel Fitness Belt (K102295)
Gymform Dual Shape flex belt (K111781)
Contour Technology Muscle Stimulator, Model: MX9 (K111476)
Prospera OTC TENS Electronic Pulse Massager (K122744)
Body Control System '4M' (K092476)

Submission Summary (Full Text)

{0}------------------------------------------------ Well Brain International Ltd. Sponsor: Subject Device: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 File No.: 510(k) submission report (V1.0), Chapter 6 Chapter 6. 510(k) Summary ## K130074 # 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. Submitter's Information - � 510(k) Owner's Name: Well Brain International Ltd. - � Establishment Registration Number: 3004950644 - Address: Room 1212, Harbour Crystal Centre, No. 100 Granville Road, Tsim Sha Tsui East, Kowloon, � Hong Kong SAR, China - � Phone: (852) 2619-0833 - Fax: (852) 2429-0960 � - ◆ Contact Person: Victor K Wai - � Email: victor@wellbrain-intl.com ### 2. Subject Device Information - GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 � Trade Name: - Powered muscle stimulator Common Name: � - Stimulator, Muscle, Powered, For muscle conditioning Classification name: � - Physical Medicine � Review Panel: - NGX Product Code: � - 2 � Regulation Class: - 890.5850 Regulation Number: � #### 3. Predicate Device Information | Sponsor | Leto Enterprises Incorporation | Well Brain International Ltd. | Contour Technology | Prospera Corporation | SPORT- ELEC S.A. | |----------------|---------------------------------------|-------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------|-----------------------------------| | Device Name | X2ABS Dual Channel Fitness Belt | Gymform Dual Shape flex belt | Contour Technology Muscle Stimulator, Model: MX9 | Prospera OTC TENS Electronic Pulse Massager | Body Control System "4M" | Report by Well Brain International Ltd. AUG 1 5 2013 {1}------------------------------------------------ | Sponsor: | Well Brain International Ltd. | |-----------------|--------------------------------------------| | Subject Device: | GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 | | File No.: | 510(k) submission report (V1.0), Chapter 6 | | 510(k) Number | K102295 | K111781 | K111476 | K122744 | K092476 | |----------------------|----------|----------|----------|----------|----------| | Product Code | NGX | NGX | NGX | NGX | NGX | | Regulation Number | 890.5850 | 890.5850 | 890.5850 | 890.5850 | 890.5850 | | Regulation Class | 2 | 2 | 2 | 2 | 2 | #### 4. Device Description The ABS-A-ROUND is a three-channel battery operated muscle stimulation system specifically designed to training muscles. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The stimulation of each channel is active atternately for 2 cycles with its set output intensity level and mode program in below default activation sequence: F channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then L channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then R channel is active for 180 seconds solely, stop for 10 seconds as idle interval; repeat one cycle with above activation sequence. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. It is comprised of an electronic stimulator module for signal generation, two belts for fixation, and electrodes for signal connection to skin. The electrodes are replaceable. Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user. #### 5. Intended Use / Indications for Use The GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. #### 6. Performance Summary Testing has been carried out to assure compliance with recognized electrical safety standards: - IEC 60601-1 and IEC 60601-2-10 standards for electrical safety Report by Well Brain International Ltd. {2}------------------------------------------------ | Sponsor: | Well Brain International Ltd. | |-----------------|---------------------------------------------| | Subject Device: | GYMFORM ® ABS-A-ROUND, Model: VDPGYCIND0016 | | File No.: | 510(k) submission report (V1.0), Chapter 6 | - IEC 60601-1-2 standard for electromagnetic compatibility Performance data has been verified according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The waveform test report has also been provided to verify the parameters of the device. #### 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, mode of operation, and intended use of GYMFORM® ABS-A-ROUND 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 of Comparison | Subject Device | Predicate Device | | | Remark | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name and Model | GYMFORM® ABS-A- ROUND | X2ABS Dual Channel Fitness Belt | Gymform Dual Shape flex belt | Contour Technology Muscle Stimulator, Model: MX9 | Prospera OTC TENS Electronic Pulse Massager | Body Control System '4M' | | | 510 (K) Number | Applying | K102295 | K111781 | K111476 | K122744 | K092476 | -- | | Intended Use & Indications for Use | The GYMFORM® ABS-A- ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A- ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt | The X2ABS Dual Channel Fitness Belt is intended for use by healthy persons to apply trans- coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: Improvement of muscle tone of the muscles in the abdomen. | The Gymform Dual Shaper flex belt is a powered muscle stimulator intended for abdominal muscle conditioning. | The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance . The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training. The Contour Technology Muscle Stimulator Ab Belt accessory is | To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | The Body Control -4M' is intended for use bv healthy persons to apply trans- coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes. Improvement of muscle tone and firmness, for strengthenin g muscles in arms, abdomen, | SE Note 1 | Report by Well Brain International Ltd. {3}------------------------------------------------ | Sponsor: | Well Brain International Ltd. | |----------|---------------------------------------------------------------| | | Subject Device: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 | | | File No .: 510(k) submission report (V1.0), Chapter 6 | | | accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. | | | intended for use on abdominal muscles only for strengthenin g and toning of abdominal muscles. The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only. | | thighs and buttocks areas. | | Power | 3 x 1.5V AAA batteries | 2 x 1.5V AAA batteries | 12V AC Adapter | 4 x 1.5V AAA batteries | 6V battery | 3 x 1.5V AAA batteries | SE Note 4 | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------|----------------------------------------|--------------| | Specification | | | | | | | | Electrode Size (cm²) | Small: 33.0 x 1 piece Big: 34.5 x 2 pieces | 32 | -- | 40.5 | -- | 128 | SE Note 5 | | Channel | 3 | 2 | 1 | 2 | 2 | 2 | SE Note 2 | Maximum Current Density(mA/ cm² @ 500Ω) | 0.057 (for the smallest size electrode 33.0 cm²) | 0.032 (for the smallest size electrode 32.0 cm²) | -- | 0.55 (for the smallest size electrode 40.5 cm²) | 1.4 | -- | SE Note 5 | | Synchronous /Alternating channels | Alternating | Synchronous | (1 Channel) | -- | Alternating | … | SE | Timer Range | Default time (maximum) is 19 minutes. | Default time is 10 minutes, minimum time is 5 minutes | Default time is 10 minutes | -- | 15 minutes | Default time is 4 minutes 30 sec | SE | | Stimulated muscles | Abdomen, left waist and right waist, arms, legs, thighs and buttocks | Abdomen | Abdomen | Abdomen and lower back | Shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) | Arms, abdomen, thighs and buttocks areas | SE | LCD display | Indicate the following information: Power on/off, Channel indication, Intensity level, Mode selection. | Indicate the following information: Sound on/off, Keylock, Low battery, Channel indication, Intensity level, Mode selection. | Indicate the following information: Sound on/off, Keylock, Low battery, Channel indication, Intensity level. | -- | Indicate On/Off status only. | -- | SE | | Number of programs | 6 | 8 | 5 | | 3 | 4 | SE Note 2 | Environment for operating | Temperature : 5 ~ 40°C Humidity: 20 ~ 65% RH | Temperature : 5 ~ 40°C Humidity: 20 ~ 65% RH | Temperature : 35 °F to 95 °F Humidity: 20 to 80% RH | -- | -- | -- | SE Note 4 | | Number of phases variations | 99 steps | 28 steps | 99 steps | == | -- | -- | SE Note 2 | Environment for storage | Temperature : 0 ~ 40°C Humidity: 10 ~ 90% RH | Temperature : 0 ~ 40°C Humidity: 10 ~ 90% RH | Temperature : 32 °F to 131 °F Humidity: 10 to 90% RH | -- | -- | -- | SE Note 4 | | Number of adjustable independent outputs | 3 | 2 | 1 | -- | 3 | 2 | SE | Standards | | | | | | | | | Output | From 0 to 118 V (From 0 to 1000 Ohm) | From 0 to 60 mA (From O to 1000 Ohm) | From 5.6 to 40 mA (From 0 to 500 Ohm) | From 0 to 22 mA (From 0 to 500 Ohm) | | From 0 to 70mA from 0 to 60V- from 0 to 1000 Ohm) | SE Note 3 | Biocompatibi lity | 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 | All user directly contacting materials are compliance with ISO10993-5 and ISO10993- 10 requirements | -- | -- | SE | | Frequency range(Hz) | 2, 10, 50, 90, 120 | 8.5 to 64 | 15,18, 25,30, 35 | 1 to 120 | 1 to 100 | 50 to 70 | SE Note 3 | Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | -- | -- | SE | | Pulse width range(us) | 100 / 120 | 220 | 250 | 340 | 120 to 6800 | 200 | ട്ട് Note 3 | | | | | | | | | | Contraction and Relaxation time | Adjustable, due to different modes. | Adjustable, due to different modes. | Adjustable, due to different modes. | -- | Adjustable, due to different modes. | Adjustable, due to different modes. | SE | | | | | | | | | · . : {4}------------------------------------------------ #### Well Brain International Ltd. Sponsor: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 Subject Device: 510(k) submission report (V1.0), Chapter 6 File No.: {5}------------------------------------------------ | Sponsor: | Well Brain International Ltd. | |-----------------|--------------------------------------------| | Subject Device: | GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 | | File No.: | 510(k) submission report (V1.0), Chapter 6 | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | -- | -- | SE | |-----|------------------------------|------------------------------|------------------------------|------------------------------|----|----|----| |-----|------------------------------|------------------------------|------------------------------|------------------------------|----|----|----| #### Comparison in Detail(s): #### Note 1: Although the muscles for intended use of subject device are different from predicate devices, we can find that the predicate device Contour Technology Muscle Stimulator (K111476), Prospera OTC TENS Electronic Pulse Massager (K122744) and Body Control System '4M' (K092476) can also be used on the same muscles according to the device description of 510(k) summary. So the subject device and predicate device K111476 have the same intended use aspect. ### Note 2: Although the number of channels, programs, and phase variations of subject device are different from the predicate devices, they are all compliance with IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue. #### Note 3: Although the "Output", "Frequency range" and "Pulse width range" of subject device are a little different from the predicate devices, they are all compliance with IEC 60601-2-10 requirement and FDA guidance requirement for the EMS. So the differences of function will not raise any safety or effectiveness issue. #### Note 4: Although the power, operating and storage environment are a little different from the predicate devices, they are all compliance with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue. #### Note 5: Although the electrode size and maximum current density of subject device are a little different from the predicate devices, they are all compliance with IEC 60601-2-10 requirement and FDA guidance requirement for the EMS. So the differences of function will not raise any safety or effectiveness issue. 8. Date of the summary prepared: August 12, 2013 Report by Well Brain International Ltd. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. ### 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 August 15, 2013 Well Brain International Ltd. c/o Victor K Wai Managing Director Rm. 1212, 12 Floor, Harbour Crystal Centre No. 100 Granville Road, Tsim Sha Tsui East Kowloon, Hong Kong China 999077 Re: K130074 Trade/Device Name: Gymform® ABS-A-ROUND, model VDPGYCIND0016 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: July 8, 2013 Received: July 11, 2013 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 {7}------------------------------------------------ Page 2 - Mr. Victor K. Wai 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-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" (2) 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 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 {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _ K130074 Device Name: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016 Indications For Use: The GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Joyce M. Whang -S (Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) 510(k) Number Page 1 of 1

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GYMFORM ABS-A-ROUND

Device Facts

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Device Story

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Predicate Devices

Submission Summary (Full Text)

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