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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the GYMFORM® ABS-A-ROUND device, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions primarily focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical studies that would typically define "acceptance criteria" and "device performance" in the way one might expect for a novel device or a high-risk device. The "performance" discussed here largely refers to compliance with electrical safety and EMC standards, and a comparison of technical specifications to predicate devices. There is no mention of a formal clinical performance study in the provided text that would establish typical diagnostic or therapeutic performance metrics like sensitivity, specificity, accuracy, or effect sizes for human improvement.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, the "acceptance criteria" are primarily related to safety, electrical performance, and substantial equivalence to predicate devices, rather than clinical efficacy. The reported "performance" aligns with these compliance aspects.

Acceptance Criterion (Implied/Explicit)	Reported Device Performance
Electrical Safety	Complies with IEC 60601-1 and IEC 60601-2-10 standards.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 standard.
Waveform Parameters	Waveform test report provided to verify device parameters.
Biocompatibility	All user-contacting materials comply with ISO10993-5 and ISO10993-10.
Substantial Equivalence	Considered substantially equivalent to predicate devices; differences do not raise new safety or effectiveness issues.
Intended Use	Stimulate healthy muscles to improve/facilitate muscle performance; considered a technique/method for muscle training.
Functional Specifications	Different from predicate devices in channels, programs, phase variations, output, frequency range, pulse width, power, operating/storage environment, electrode size, and maximum current density, but all comply with relevant IEC standards and FDA guidance, thus not raising safety/effectiveness issues.

Study Details (Based on available information)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is mentioned for evaluating muscle performance or clinical outcomes. The "testing" mentioned refers to compliance with electrical safety and EMC standards. These are typically bench tests or simulations, not human subject studies.
- The manufacturer is Well Brain International Ltd., located in Hong Kong SAR, China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a study requiring expert-established ground truth for a test set in the context of clinical performance. The documentation focuses on engineering and regulatory compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a powered muscle stimulator, not an imaging analysis or diagnostic AI device. There is no mention of an MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a direct-use muscle stimulator, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "truth" or reference used in this submission relates to established electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility standards (ISO10993-5, ISO10993-10), as well as FDA guidance for EMS devices. These are engineering and regulatory benchmarks, not clinical ground truth.
The sample size for the training set
- Not applicable. This device does not use machine learning or require a training set in the conventional sense.
How the ground truth for the training set was established
- Not applicable. As above, no training set or associated ground truth establishment process is mentioned.

Summary of the 510(k) Submission's Approach:

The Well Brain International Ltd. 510(k) submission for the GYMFORM® ABS-A-ROUND is a typical example of demonstrating substantial equivalence for a Class II medical device. The "acceptance criteria" are primarily regulatory and engineering compliance requirements. The "study" mentioned consists of testing the device against recognized electrical safety, EMC, and biocompatibility standards, and then demonstrating that its technical specifications and intended use are similar enough to existing, legally marketed predicate devices such that any differences do not raise new concerns about safety or effectiveness. There is no clinical performance study data presented in this summary to establish efficacy or diagnostic accuracy, which is common for devices of this type seeking a 510(k) clearance based on substantial equivalence.

Summary

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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	LetoEnterprisesIncorporation	Well BrainInternationalLtd.	ContourTechnology	ProsperaCorporation	SPORT-ELEC S.A.
DeviceName	X2ABS DualChannelFitness Belt	GymformDual Shapeflex belt	ContourTechnologyMuscleStimulator,Model:MX9	ProsperaOTC TENSElectronicPulseMassager	BodyControlSystem"4M"

Report by Well Brain International Ltd.

AUG 1 5 2013

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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
ProductCode	NGX	NGX	NGX	NGX	NGX
RegulationNumber	890.5850	890.5850	890.5850	890.5850	890.5850
RegulationClass	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

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.

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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 ofComparison	SubjectDevice	Predicate Device			Remark
DeviceName andModel	GYMFORM®ABS-A-ROUND	X2ABS DualChannelFitness Belt	GymformDual Shapeflex belt	ContourTechnologyMuscleStimulator,Model: MX9	ProsperaOTC TENSElectronicPulseMassager	Body ControlSystem '4M'
510 (K)Number	Applying	K102295	K111781	K111476	K122744	K092476	--
IntendedUse &Indicationsfor Use	TheGYMFORM®ABS-A-ROUND isintended tostimulatehealthymuscles inorder toimprove orfacilitatemuscleperformance.The ABS-A-ROUND maybeconsidered atechnique ormethod formuscletraining.The 3-areabelt isintended foruse on themuscles inabdomen,left waist andright waistalternately.The Mini belt	The X2ABSDualChannelFitness Beltis intendedfor use byhealthypersons toapply trans-coetaneouselectricalmusclestimulation(EMS)through skincontactelectrodesfor thefollowingpurposes:Improvementof muscletone of themuscles intheabdomen.	TheGymformDual Shaperflex belt is apoweredmusclestimulatorintended forabdominalmuscleconditioning.	The ContourTechnologyMuscleStimulator isintended tostimulatehealthymuscles inorder toimprove orfacilitatemuscleperformance. TheContourTechnologyMuscleStimulatormaytherefore beconsidered atechnique ormethod formuscletraining.The ContourTechnologyMuscleStimulatorAb Beltaccessory is	To be usedfortemporaryrelief of painassociatedwith soreand achingmuscles inthe shoulder,waist, back,neck, upperextremities(arm), andlowerextremities(leg) due tostrain fromexercise ornormalhouseholdworkactivities.	The BodyControl -4M'is intendedfor use bvhealthypersons toapply trans-coetaneouselectricalmusclestimulation(EMS)through skincontactelectrodesfor thefollowingpurposes.Improvementof muscletone andfirmness, forstrengthening muscles inarms,abdomen,	SENote 1

Report by Well Brain International Ltd.

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Sponsor:	Well Brain International Ltd.
	Subject Device: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016
	File No .: 510(k) submission report (V1.0), Chapter 6

	accessory isintended foruse on themuscles inarms, legs(lowerextremities),thighs andbuttocksareasseparately.			intended foruse onabdominalmuscles onlyforstrengthening and toningof abdominalmuscles.The ContourTechnologyMuscleStimulatorBackPadaccessory isintended foruse on thelower backmusclesonly.		thighs andbuttocksareas.		Power	3 x 1.5VAAAbatteries	2 x 1.5VAAAbatteries	12V ACAdapter	4 x 1.5VAAAbatteries	6V battery	3 x 1.5VAAAbatteries	SENote 4
Specification								ElectrodeSize (cm²)	Small: 33.0 x1 pieceBig: 34.5 x 2pieces	32	--	40.5	--	128	SENote 5
Channel	3	2	1	2	2	2	SENote 2	MaximumCurrentDensity(mA/cm² @500Ω)	0.057(for thesmallest sizeelectrode33.0 cm²)	0.032(for thesmallest sizeelectrode32.0 cm²)	--	0.55 (for thesmallest sizeelectrode40.5 cm²)	1.4	--	SENote 5
Synchronous/Alternatingchannels	Alternating	Synchronous	(1 Channel)	--	Alternating	…	SE	Timer Range	Default time(maximum)is 19minutes.	Default timeis 10minutes,minimumtime is 5minutes	Default timeis 10minutes	--	15 minutes	Default timeis 4 minutes30 sec	SE
Stimulatedmuscles	Abdomen,left waist andright waist,arms, legs,thighs andbuttocks	Abdomen	Abdomen	Abdomenand lowerback	Shoulder,waist, back,neck, upperextremities(arm), andlowerextremities(leg)	Arms,abdomen,thighs andbuttocksareas	SE	LCD display	Indicate thefollowinginformation:Power on/off,Channelindication,Intensitylevel, Modeselection.	Indicate thefollowinginformation:Soundon/off,Keylock,Low battery,Channelindication,Intensitylevel, Modeselection.	Indicate thefollowinginformation:Soundon/off,Keylock,Low battery,Channelindication,Intensitylevel.	--	IndicateOn/Offstatus only.	--	SE
Number ofprograms	6	8	5		3	4	SENote 2	Environmentfor operating	Temperature: 5 ~ 40°CHumidity: 20~ 65% RH	Temperature: 5 ~ 40°CHumidity: 20~ 65% RH	Temperature: 35 °F to95 °FHumidity: 20to 80% RH	--	--	--	SENote 4
Number ofphasesvariations	99 steps	28 steps	99 steps	==	--	--	SENote 2	Environmentfor storage	Temperature: 0 ~ 40°CHumidity: 10~ 90% RH	Temperature: 0 ~ 40°CHumidity: 10~ 90% RH	Temperature: 32 °F to131 °FHumidity: 10to 90% RH	--	--	--	SENote 4
Number ofadjustableindependentoutputs	3	2	1	--	3	2	SE	Standards
Output	From 0 to118 V (From0 to 1000Ohm)	From 0 to 60mA (From Oto 1000Ohm)	From 5.6 to40 mA(From 0 to500 Ohm)	From 0 to 22mA (From 0to 500 Ohm)		From 0 to70mA from 0to 60V- from0 to 1000Ohm)	SENote 3	Biocompatibility	All userdirectlycontactingmaterials arecompliancewithISO10993-5andISO10993-10requirements	All userdirectlycontactingmaterials arecompliancewithISO10993-5andISO10993-10requirements	All userdirectlycontactingmaterials arecompliancewithISO10993-5andISO10993-10requirements	All userdirectlycontactingmaterials arecompliancewithISO10993-5andISO10993-10requirements	--	--	SE
Frequencyrange(Hz)	2, 10, 50, 90,120	8.5 to 64	15,18, 25,30,35	1 to 120	1 to 100	50 to 70	SENote 3	ElectricalSafety	Comply withIEC 60601-1and IEC60601-2-10	Comply withIEC 60601-1and IEC60601-2-10	Comply withIEC 60601-1and IEC60601-2-10	Comply withIEC 60601-1and IEC60601-2-10	--	--	SE
Pulse widthrange(us)	100 / 120	220	250	340	120 to 6800	200	ട്ട്Note 3
ContractionandRelaxationtime	Adjustable,due todifferentmodes.	Adjustable,due todifferentmodes.	Adjustable,due todifferentmodes.	--	Adjustable,due todifferentmodes.	Adjustable,due todifferentmodes.	SE

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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 withIEC 60601-1-2	Comply withIEC 60601-1-2	Comply withIEC 60601-1-2	Comply withIEC 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.

Date of the summary prepared: August 12, 2013

Report by Well Brain International Ltd.

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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

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Indications for Use

510(k) Number (if known): _ K130074

Device Name: GYMFORM® ABS-A-ROUND, Model: VDPGYCIND0016

Indications For Use:

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

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).