Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a basic electrical muscle stimulator with user-controlled intensity and pre-set parameters. There is no mention of adaptive algorithms, learning from user input, or any other characteristics typically associated with AI/ML. The performance studies focus on electrical safety, EMC, and basic software validation, not AI/ML performance metrics.

Therapeutic

Yes
The device is described as a muscle stimulation system intended to stimulate healthy muscles to improve or facilitate muscle performance, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition or improve bodily function.

Diagnostic

No

Explanation: The device is described as a muscle stimulation system intended to "stimulate healthy muscles in order to improve or facilitate muscle performance." It does not mention any function for identifying, diagnosing, or monitoring medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a console for signal generation, two belts, and electrode pads, which are physical hardware components. The performance studies also include electrical safety, electromagnetic compatibility, and waveform testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical therapy or fitness-related application, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a muscle stimulation system that applies electrical current to the skin to stimulate muscles. This is a therapeutic or performance-enhancing device, not a diagnostic one.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.

The device falls under the category of a powered muscle stimulator, which is a type of medical device used for physical therapy or muscle conditioning.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

NGX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdomen, lower back, arms, legs, thighs, buttocks

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130074, K111476

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

1

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 (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" (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 (800) 638-2041 or (301) 796-7100 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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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: (852) 2619-0833
� Fax: (852) 2429-0960
� Contact Person: Victor K Wai
Email: victor@wellbrain-intl.com �

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

Device	Predicate Device I	Predicate Device II
Sponsor	Well Brain International Ltd.	Contour Technology

4

| Predicate

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

5

� 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
of

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


Environment for storage	Temperature: 0~40° C
Humidity: 10 ~90% RH	Temperature: 5 ~ 45°C
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


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	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

6

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

7

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

8

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

9

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

10

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

Comparison in Detail(s):

Note 1:

Although the power sources, patient leakage current in normal condition and single fault condition, number of channels, synchronous or alternating, method of channel isolation, number intensity level, timer range console weight, accessories weight, console dimensions, electrode pad dimension of subject device are a

11

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

little different from the predicate devices, they are all compliant with requirements of IEC 60601-1, IEC 60601-1-2 and Guidance for Powered Muscle Stimulator. So the differences of the function specifications will not raise any safety or effectiveness issue.

Note 2:

Although the maximum output voltage, maximum current density, frequency range, pulse width range, pulse duration, contraction time, net charge, maximum phase charge, maximum current density, maximum power density, on time, off time, contraction time and duty cycle of subject device are a little different from the predicate devices, they are all compliant with the requirements of IEC 60601-1, IEC 60601-2-10, and Guidance for Powered Muscle Stimulator. So the differences of function specification will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "GYMFORM® ABS& CORE" is Substantial Equivalence to the predicate device.