Predicate Devices

K102295, K111781, K111476, K122744, K092476

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a simple muscle stimulation system with pre-set programs and user-adjustable intensity, with no mention of adaptive learning, data analysis, or any characteristics typically associated with AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

Therapeutic

No.
The intended use states it is to "stimulate healthy muscles in order to improve or facilitate muscle performance," not to treat or diagnose a disease or condition. It is described as a "technique or method for muscle training."

Diagnostic

No

The device is described as a muscle stimulation system intended to stimulate healthy muscles to improve or facilitate muscle performance and for muscle training. It sends electrical current to targeted muscle groups. There is no mention of it being used to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "three-channel battery operated muscle stimulation system" comprised of an "electronic stimulator module," "belts for fixation," and "electrodes for signal connection to skin." This indicates it is a hardware device with electrical components, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the GYMFORM® ABS-A-ROUND is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance" and for "muscle training." This involves direct interaction with the body for therapeutic or training purposes.
Device Description: The device is a "muscle stimulation system" that sends electrical current to targeted muscle groups through electrodes placed on the skin. This is a physical intervention, not a test performed on samples taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a person's health condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GYMFORM® ABS-A-ROUND does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

NGX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdomen, left waist, right waist, arms, legs (lower extremities), thighs, buttocks areas

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)

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
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.

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

Not Found

Predicate Device(s)

K102295, K111781, K111476, K122744, K092476

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

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.

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

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