The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.

Device Description

The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.

The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles.

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.

There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.

Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.

AI/ML Overview

The provided document, a 510(k) Summary for the Gymform® TOTAL ABS, Model: WB-245, describes the device's technical specifications and claims substantial equivalence to predicate devices. However, it does not detail specific acceptance criteria for a study proving the device meets those criteria in clinical performance metrics. Instead, the document focuses on demonstrating safety and performance through compliance with recognized standards and a usability study, and by comparing its technical specifications to legally marketed predicate devices.

Here's an analysis of the provided information, structured around your request, with an emphasis on what is available and what is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices, which generally implies that if the predicate device is safe and effective, and the new device is sufficiently similar and meets safety standards, it is also safe and effective.

The performance data summarized focuses on technical benchmarks and compliance:

Category	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10
EMC	Compliance with IEC 60601-1-2	Comply with IEC 60601-1-2
Biocompatibility	Compliance with ISO 10993-5, ISO 10993-10	Non cytotoxic, No skin sensitization, No skin irritation
Software Integrity	Compliance with FDA Guidance for Software in Medical Devices (Moderate concern)	Software verification and validation testing conducted and documented
Waveform Parameters	Verified to demonstrate substantial equivalence to predicate devices	Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density verified
Usability (OTC)	Lay user can: 1) Self-select, 2) Apply safely, 3) Understand indications/contraindications/warnings	Usability testing completed in 24 subjects; tests demonstrate device meets requirements
Max Output Voltage	Comparable to predicate devices, within safe limits	81.6V @ 500Ω, 96V @ 2kΩ, 99.2V @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices.
Max Output Current	Comparable to predicate devices, within safe limits	163mA @ 500Ω, 48mA @ 2kΩ, 9.92mA @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices.
Frequency Range	Comparable to predicate devices, within safe limits	50, 60, 70 Hz. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance.
Pulse Width Range	Comparable to predicate devices, within safe limits	200 us. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance.
Max Current Density	Compliance with IEC 60601-2-10 and FDA guidance	0.041 mA/cm² @ 500Ω. Compliant with standards.
Max Power Density	Compliance with IEC 60601-2-10 and FDA guidance, below 0.25 W/cm²	28.81 µW/cm². Compliant with standards and below 0.25 W/cm².

2. Sample Size for the Test Set and Data Provenance

Usability Study Test Set: 24 subjects
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "Usability testing (OTC Study)," which is typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable for a usability study. The "ground truth" for a usability study is typically the direct observation of user interaction and self-reported comprehension, not expert consensus on a medical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. Usability studies do not typically involve adjudication in the same way clinical diagnostic studies do. The assessment is usually based on predefined tasks and criteria for successful completion and comprehension by the "lay user."

5. 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

No MRMC comparative effectiveness study was mentioned. This device is a muscle stimulator, not an AI-powered diagnostic tool for interpretation by human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is not an algorithm for diagnosis. Its performance is inherent in its electrical stimulation output and how users interact with it. The stated performance evaluations (electrical, EMC, biocompatibility, waveform, usability) are effectively "standalone" in that they assess the device itself without requiring a human medical expert to interpret its output for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For Biocompatibility: Laboratory testing results based on established ISO standards.
For Electrical Safety/EMC/Waveform: Measurement against recognized engineering standards (IEC, FDA guidance).
For Usability: User performance and comprehension against specified usability objectives for "lay users." There isn't a "ground truth" in the diagnostic sense, but rather a determination of whether users can operate the device safely and effectively according to instructions.

8. The sample size for the training set

Not applicable. This document pertains to the evaluation of a physical medical device (muscle stimulator) rather than an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/ML algorithm was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2021

Well Brain International Ltd. Jet Li Regulation Manager Guangzhou Kinda Biological Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou, Guangdong China

Re: K202653

Trade/Device Name: Gymform Total ABS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 14, 2020 Received: December 18, 2020

Dear Jet Li:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, Ph.D. Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K202653

Device Name

Gymform® TOTAL ABS, Model: WB-245

Indications for Use (Describe)

The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

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

☑ New Construction (Lot/SFR, 201+ Lots)
-----------------------------------------

__ 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 K202653

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR807.92.

1. Submitter's Information

510(k) Sponsor: Well Brain International Ltd. �
Address: Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent, Kwai Chung, Hong Kong, China �
Phone: (852) 2619-0833 �
Fax: (852) 2429-0960 �
� Contact Person: Victor K Wai
� Email: victor@wellbrain-intl.com

Subject Device Information 2.

•	Trade Name:	Gymform® TOTAL ABS, Model: WB-245
•	Common Name:	Powered muscle stimulator
•	Classification name:	Stimulator, Muscle, Powered, For muscle conditioning
•	Review Panel:	Physical Medicine
•	Product Code:	NGX
•	Regulation Class:	2
•	Regulation Number:	890.5850

3. Application Correspondent

Application Correspondent: Guangzhou KINDA Biology Technology Co.,Ltd.

Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China �
Contact Person: Mr. Jet Li �
� Tile: Regulation Manager
� Tel: +86-18588874857
� Email:med-jl@foxmail.com

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Predicate and Reference Device Information 4.

510kNumber	K130074(Primarypredicate)	K102295(Referencedevice I)	K092476(Referencedevice II)	K183674(Referencedevice III)
Sponsor	Well BrainInternationalLtd	LetoEnterprisesIncorporation	SPORT-ELECS.A.	ShenzhenLeadingPerfectionTechnologyCo., Ltd
DeviceName	ABS - A-Round	X2ABSDualChannelFitness Belt	BodyControlSystem '4M'	ElectronicPulseStimulator,Model S3
ProductCode	NGX	NGX	NGX	NGX
RegulationNumber	890.5850	890.5850	890.5850	890.5850
RegulationClass	2	2	2	2

5. Device Description

There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.

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Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.

6. Intended Use / Indications for Use

The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

7. Performance data Summary

The Device has been evaluated the safety and performance by lab bench testing according to the following standards:

Electrical safety and electromagnetic compatibility (EMC)

IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
IEC 60601-1:2005: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10: 2012: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

Biocompatibility testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of

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Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, "as recognized by FDA. The battery of testing included the following tests:

Biological evaluation of medical device Part 10: Tests for Intracutaneos Reactivity test and skin sensitization (ISO 10993-10:2010)

Test	Test summary	Conclusion
Cytotoxicity test	Cytotoxicity Test with MTT Methodaccording to ISO 10993-5	Non cytotoxic
Skin sensitization	Skin Sensitization with test method:0.9% Sodium Chloride InjectionExtract and Sesame Oil Extractaccording to ISO 10993-10	No skin sensitization
Intracutaneous Reactivity test	Skin Intracutaneous Reactivity withtest method: 0.9% Sodium ChlorideInjection Extract and Sesame OilExtract according to ISO 10993-10	No skin irritation

Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device.

Performance verification testing:

The waveform test report has also been provided to verify the parameters of the below output current pulse waveform parameter was verified:

Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density and so on were tested to demonstrate substantial equivalence to predicate devices.

Usability study testing:

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Usability testing (OTC Study) was completed in 24 subjects to evaluate device human factors and label comprehension.

These usability study tests demonstrate that the device and its labeling can meet with the requirement:

the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

8. Clinical test

No clinical testing is need

9. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, mode of operation, and intended use of Gymform® TOTAL ABS( Model: WB-245) is substantially equivalent to the predicate devices quoted above.

Microcurrent technology (Electro Muscle Stimulation-EMS) is the technological principle for both the subject and predicate devices. . The device is design based on Microcurrent (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.

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

Elements ofComparison	Subject Device	Primarypredicate	Referencedevice I	Referencedevice II	Reference device III	Remark
Sponsor	Well BrainInternational Ltd	Well BrainInternational Ltd	LetoEnterprisesIncorporation	SPORT-ELECS.A.	Shenzhen LeadingPerfection TechnologyCo., Ltd	--
Device Nameand Model	Gymform®TOTAL ABS,(Model: WB-245)	ABS -A- Round	X2ABS DualChannelFitness Belt	Body ControlSystem '4M'	Electronic PulseStimulator, Model S3	--
510 (K)Number	Applying	K130074	K102295	K092476	K183674	--
Indicationsfor Use	The Gymform®TOTAL ABS(Model: WB-245)	TheGYMFORM6ABS-A-ROUNDis intended to	The X2ABSDual ChannelFitness Belt isintended for	The BodyControl -4M' isintended for useby healthy	Mode 1 (PMS):To be used forstimulating healthy	Minordifference
	is intended to	stimulate	use by healthy	persons to apply	muscles in order to	Note 1
	stimulate healthymuscles in orderto improve orfacilitate muscleperformance..	healthymuscles inorder toimprove orfacilitatemuscleperformance.The ABS-A-ROUND maybe considered atechnique ormethod for	persons toapply trans-coetaneouselectricalmusclestimulation(EMS) throughskin contactelectrodes forthe follow ingpurposes:	trans-coetaneouselectrical musclestimulation(EMS) throughskin contactelectrodes forthe follow ingpurposes.Improvement ofmuscle tone andfirmness, for	improve andfacilitate muscleperformance.Mode 2 (TENS):To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, neck, upperextremities (arm), lowerextremities (leg),abdomen and bottomdue to strain fromexercise or normalhousehold workactivities	Forpredicate deviceIV, onlycompared with itsindication for usein EMSmode.
	small belt forworking the legand armmuscles,intended for useon the musclesin arms, legs(low erextremities) andthighs areasseparately.	muscle training.The 3-area beltis intended foruse on themuscles inabdomen, leftwaist and rightw aistalternately.The Mini beltaccessory isintended foruse on themuscles inarms, legs(low erextremities),thighs andbuttocks areasseparately..	of muscle toneof the musclesin theabdomen.	strengtheningmuscles in arms,abdomen, thighsand buttocksareas.
Channel	1	3	2	2	1	SE
Synchronous/Alternatingchannels	Synchronous	--	Synchronous	--	Symmetricalrectangular	SE
Stimulatedmuscles	Abdomen, arms,legs and thighs	Arms, Waist,abdomen,legs, thighsand buttocksareas	Abdomen	Arms, abdomen,thighs andbuttocks areas	Arm, leg, abdomen,hip, feet	SE
Number ofprograms	6	6	8	4	1	SE
Number ofoutputintensity level	10 steps	99 steps	28 steps	--	--	MinordifferenceNote 2
Maximumoutputvoltage	81.6V @ 500Ω96V @ 2kΩ99.2V @ 10kΩ	108V @ 500 Ω124V @ 2k Ω126V @ 10k Ω	from 0 to 60V-from 0 to1000 Ohm)	from 0 to 60V-from 0 to 1000Ohm)	40±20% V @ 500 Ω64±20%V @ 2k Ω76±20% V @ 10k Ω	MinordifferenceNote 3
MaximumOutputCurrent	163mA @ 500Ω48mA @ 2kΩ9.92mA @ 10kΩ	216mA@ 500Ω62mA@ 2k Ω12.6mA@ 10kΩ	From 0 to 60mA (From 0 to1000 Ohm)	From 0 to 70mA	80±20%mA@500ohm;32±20% @2kohm;7.6±20% mA@10kohm	MinordifferenceNote 3
Frequencyrange(Hz)	50,60,70 Hz	2 Hz, 10 Hz,50 Hz, 90 Hz,120 Hz	8.5 to 64 Hz	50 to 70 Hz	Mode 1: 4-35Hz	MinordifferenceNote 3
Pulse w idthrange(us)	200	100 us / 120 us	220	200	200	MinordifferenceNote 3
ContractionandRelaxationtime	Adjustable, dueto differentmodes.	Adjustable, dueto differentmodes.	Adjustable,due todifferentmodes.	Adjustable, dueto differentmodes.	--	SE
Pow er	3 x 1.5V AAAbatteries	3 x 1.5V AAAbatteries	2 x 1.5V AAAbatteries	3 x 1.5V AAAbatteries	USB rechargeablebattery, 3.7V	SE
ElectrodeSize (cm²)	34.5 x 2 pieces;total 5 pairs ofelectrode pad	128	32	128	--	MinordifferenceNote 4
MaximumCurrentDensity(mA/cm² @ 500Ω)	0.041 (mA/cm²@ 500Ω)	0.057 mA/cm² @500 Ω	0.032(for thesmallest sizeelectrode 32.0cm²)	--	Hips pad: 0.079mA/cm²Arms and legs pad:0.104 mA/cm²Abdomen pad: 0.111	MinordifferenceeNote 5
MaximumpowerDensity	28.81μW/cm²	53.8 μW/cm² @500 Ω	16. 38 μW/cm²	--	Hips pad:100μW/cm²;Arms and legs pad:200μW/cm²;Abdomen pad:200μW/cm²;Feet pad:30μW/cm²	MinordifferenceeNote 5
					Feet pad: 0.016 mA/cm²

Timer Range	Default time is10minutes.	Default time is19 minutes	Default time is10 minutes,minimum timeis 5 minutes	Default time is 4minutes 30 sec	25 min	MinordifferenceeNote 6
LED display	Indicate thefollowinginformation:On/offstatus, Modeselection.	--	Indicate thefollowinginformation:Sound on/off,Keylock, Lowbattery,Channelindication,Intensity level,Modeselection.	--	On/off status, Lowbattery	SE
Environmentfor operating	Temperature: 0~ 35° CHumidity: <85%RH	--	Temperature:5 ~ 40° CHumidity: 20 ~65% RH	--	--	MinordifferenceeNote 7
Environmentfor storage	Temperature: 0 ~40° CHumidity: 10 ~90% RH	--	Temperature:0 ~ 40° CHumidity: 10 ~90% RH	--		SE
	All user directlycontacting		All userdirectly		All user directly

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Biocompatibility	materials arecompliance withISO10993-5 andISO10993-10requirements.	--	contactingmaterials arecompliancewithISO10993-5andISO10993-10requirements.	--	contacting materialsare compliance w ithISO10993-5 andISO10993-10requirements.	SE

ElectricalSafety	Comply w ith IEC60601-1 and IEC60601-2-10	Comply w ithIEC 60601-1and IEC 60601-2-10	Comply w ithIEC 60601-1and IEC60601-2-10	Comply w ith IEC60601-1 andIEC 60601-2-10	Comply w ith IEC60601-1 and IEC60601-2-10	SE
EMC	Comply w ith IEC60601-1-2	Comply w ithIEC 60601-1-2	Comply w ithIEC 60601-1-2	Comply w ith IEC60601-1-2	Comply w ith IEC60601-1-2	SE

Comparison in Detail(s):

Note 1:

Even there is minor difference on the description words about Indications for use between subject device and predicate device. But actually, the indications for use and treatment parts are same to the primary predicate device I; And the indications for use of other predicate devices also cover the indications for use of subject device. So the differences of the statement of indications for use will not raise any safety or effectiveness issue.

Note 2:

There is difference on Number of output intensity level between subject device and predicate devices, but the key parameter which affect treatment should be output voltage, current, waveform. It's level number do not affect its treatment, So the differences of the level number of output intensity will not raise any safety or effectiveness issue.

Note 3:

For maximum output voltage, Maximum output current:

Even the maximum output voltage and current for the subject device are lower than the primary predicate device (K130074). The maximum output voltage and current reflect to the setting value of the highest intensity level of the device. Not each user need the highest intensity level, the user will change the level setting according to their muscle stimulation feeling when operation. And the subject device's max output current value are covered in the output voltage and current range between primary predicate device and predicate device IV(K183674), so we can conclude that the minor difference of maximum output voltage/ output current between subject device and predicate devices would not affect effectiveness for the subject devices.

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Although the "Frequency range", "Pulse width range" and of subject device are a little different from the primary predicate device I, but the other predicate devices output specification had been cover the specification range of subject device, and they are all compliance with IEC 60601-2-10 requirement and FDA guidance requirement for the EMS. So the minor differences of function specification will not raise any safety or effectiveness issue.

Note 4:

Although the electrode size of subject device are a little different from the predicate devices, the maximum current density and maximum power density are all compliance with IEC 60601-2-10 requirement and FDA quidance requirement for the EMS, and the electrode also had 510K clearance. So the differences of electrode size will not raise any safety or effectiveness issue.

Note 5:

Although maximum current density and maximum power 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.

And for the maximum power density difference:

For the power density difference, according to the Guidance Document for Powered Muscle Stimulator 510(k)s (page 14), the power density is related to the risk of thermal burning. And the maximum power density meet with the maximum allowed value 0.25 (W/cm²) required in FDA guidance.

The effectiveness of micro current mainly depend on the output voltage; but not depend on the power density; And the power density (28.81µW/cm²) of subject device is in the range of predicate device (K130074) and the secondary predicate device (K102295), and for predicate device IV(K183674), its power density of 30 uW/cm² also was cleared in its 510K submission, which value is similar to the data of subject device.

Based on aforementioned discussion, we can conclude that the power density between the subject device and the predicate do not raise concerns of effectiveness for the subject device.

So the differences of maximum current density and maximum power density will not raise any safety or effectiveness issue.

Note6:

There is minor difference on treatment time range between subject device and predicate devices. But the treatment time can be adjusted by user as they want. So the differences of treatment time raise any safety or effectiveness issue.

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Note7:

Even there is some minor difference for operation environment between subject device and predicate device, but the operation environment do not affect the stimulation performance on body, and the device comply with IEC60601-1-11 and IEC60601-1; So the differences of treatment time range will not raise any safety or effectiveness issue.

Finial Conclusion:

The GYMFORM® TOTAL ABS,Model: WB-245 is substantially equivalence to the predicate devices.

10. Date of the summary prepared: January 14, 2021

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).