The electrical muscle stimulation (EMS) operation mode is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.

The therapeutic vibrator (Vibration) operation mode is indicated for the promotion of muscle relaxation.

Device Description

The new device with its proprietary name/model number of Gymform Dual Flex Belt/WB-162 is a single device featured with two modes of operation, independent each other - the electrical muscle stimulation for abdominal muscles conditioning and the therapeutic vibrator for abdominal muscles relaxation.

Upon selected the electrical muscle stimulator (EMS) mode, the flex belt will function as an electrical muscle stimulator capable to achieve toning and firming of muscles in the abdominal region via using transcutaneous electrical muscle stimulation which is a technology for muscle conditioning by sending a stream of electric impulses to the motor nerve of muscle via the pair of single-patient/multiple-application biocompatible cutaneous electrodes on the inner surface of the flex belt, the muscle responds to each electric impulse by producing a contractile twitch, just as it would create voluntary muscle contractions during normal training & strengthening practice, and continues to contract until the electric impulse is over the muscle then returns to its relax state. The level of muscle contraction and relaxation is determined by the electric impulse intensity and the duration applied to the motor nerve of muscle, in which is user selectable via the flex belt control panel.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Gymform Dual Flex Belt. It compares the device to a predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708), to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" is compliance with safety standards and showing "same effectiveness" as the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Compliance with recognized consensus safety standards	The device successfully passed testing for conformity with: - IEC 60601-1 (General Requirements for Safety)- IEC 60601-1-2 (Electromagnetic Compatibility)- IEC 60601-2-10 (Particular requirements for the safety of nerve and muscle stimulators)- ISO 10993-5 (In Vitro cytotoxicity)- ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity)- Complies with FDA safety requirements and IEC 60601-2-10
Effectiveness: Similar to predicate device	"effectiveness test report of Gymform Dual Flex Belt demonstrates that the new device has same effectiveness of predicate device." (Specific metrics for effectiveness are not detailed in this summary.)
Technological Characteristics: Similar to predicate device	The EMS mode is "designed, developed and built on the identical technology of electrical muscle stimulation." While specific output parameters differ (e.g., frequency ranges, max intensity levels), the overall mode of action is identical. The document states "verification and validation tests demonstrated the Gymform Dual Flex Belt maintains same safety and effectiveness as that of the cleared predicate device."
Intended Use/Indications: Identical to predicate device	The EMS mode of the Gymform Dual Flex Belt is indicated for "improvement of abdominal muscle tone, and for the development of a firmer abdomen," which is stated as "essentially identical to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions an "effectiveness test report" but does not provide any details regarding the sample size used, the characteristics of the test participants, or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the report demonstrates "same effectiveness" as the predicate device.

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

The document does not provide information about experts or ground truth establishment for an effectiveness study. The assessment of effectiveness appears to be based on an internal report that concluded similar effectiveness to the predicate device, but the methodology of that assessment is not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned or implied. The device is a direct-to-consumer electrical muscle stimulator, and comparative effectiveness studies of this nature are generally not required for 510(k) clearance in this context. The comparison is primarily against the performance characteristics of the predicate device for substantial equivalence.

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

This is not applicable as the device is a physical muscle stimulator, not an algorithm or AI system. Its performance is inherent in its electrical output and mechanical function.

7. The Type of Ground Truth Used

The document does not specify the type of "ground truth" used for effectiveness testing. Given the nature of a muscle stimulator, effectiveness might be assessed through metrics such as muscle contraction force, muscle circumference changes, or perceived muscle tone/firmness, but these details are not provided. The primary ground for clearance is "comparison of the electric muscles stimulation (EMS) mode" against a predicate.

8. The Sample Size for the Training Set

This question is not applicable as the Gymform Dual Flex Belt is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows a logo with a stylized graphic on the left and text on the right. The graphic consists of three vertical lines that curve inward and a solid black circle. To the right of the graphic, the text "Well Brain International LTD." is printed in a smaller font size. Below that, there is another line of text in a different language, possibly Chinese, with smaller characters.

JUL 1 1 2012

510(k) Summary of Safety and Effectiveness This summary is submitted in accordance with 21 CFR 807.92

1. Submitter's name:

Well Brain International, Ltd Room 1212 Harbour Crystal Centre 100 Granville Road Tsim Sha Tsui East. Kowloon Hong Kong SAR, China -

Establishment registration number: 3004950644

Name of contact person and title: Victor K Wai Managing Director

Contact person phone number: (852)2619-0833

Contact person email address: victor@wellbrain-intl.com

Date of preparation: March 28 2011

2. . Proprietary name / Model number of the device: Gymform Dual Flex Belt/ WB-162

Common name: Powered Muscle Stimulator/Therapeutic Vibrator

Classification name: Stimulator, Muscle, Power, For Muscle Conditioning; and Vibrator, Therapeutic

Classification Product code: NGX and IRO

ന്ന ·Predicate Device:

Predicate device selected for comparison of the electric muscles stimulation (EMS) mode is the Slendertone FLEX Abdominal Training System Type 515 powered muscle stimulator; assigned with the 510(k) number of K030708 to Bio-Medical Research Ltd of Ireland cleared to market commercially in the United States.

Description of device: 4.
[05-1-1] Revised March 12 2012

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Image /page/1/Picture/1 description: The image shows a logo with a stylized "W" on the left and the text "Well Brain International LTD." on the right. Below the English text is the same company name written in Chinese characters. The logo is simple and professional, likely representing a company involved in international business.

510(k) Summary of Safety and Effectiveness This summary is submitted in accordance with 21 CFR 807.92

Upon selected the therapeutic vibrator (Vibration) mode, the Gymform Dual Flex Belt (new device) will function as a therapeutic vibrator to perform muscles relaxation. The therapeutic vibrator (Vibration) mode employs the method of electric muscle massage that simulates natural massage movement of a massage therapist, using oscillating movement of the eccentric motor that installed in the instrument casing to produce linear pulling vibrations to relaxing the abdominal muscle region of a patient. Although therapeutic vibrators are classified as a Class I device, the Gymform Dual flex belt/WB-162 is considered a Class II device because it combines a powered muscle stimulator (classified under 21 CFR 890.5850 as Class II) with a therapeutic vibrator (classified under 21 CFR 890.5975 as Class I).

The Gymform Dual Flex Belt (new device) is manufactured by the submitter, the Well Brain International Ltd. with her production facility in China where a Quality Management System of ISO 9001:2008 and ISO13485:2003 is certified and currently maintained for the manufacturing of medical devices.

Intended Use: ഗ്

The Gymform Dual Flex Belt is a single device featured with two modes of operation, independent each other - the electrical muscle stimulation (EMS) for abdominal muscles conditioning and the therapeutic vibrator (Vibration) for abdominal muscles relaxing.

Indications for Use:

The electrical muscle stimulation (EMS) mode of the Gymform Dual Flex Belt is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.

[05-1-2] Revised March 12 2012

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Image /page/2/Picture/1 description: The image shows a logo with a stylized graphic on the left and text on the right. The text reads "Well Brain International LTD." on the top line and some Chinese characters on the second line. The graphic on the left appears to be a stylized representation of a spring or coil.

510(k) Summary of Safety and Effectiveness This summary is submitted in accordance with 21 CFR 807.92

The therapeutic vibrator (Vibration) mode of the Gymform Dual Flex Belt is indicated for the promotion of muscle relaxation.

6. Key Technological characteristics comparison

The electric muscles stimulation (EMS) mode of the Gymform Dual Flex Belt and the Slendertone FLEX Abdominal Training System Type 515 (K030708) are designed. developed and built on the technology of transcutaneous electrical muscle stimulation (EMS), otherwise known as neuromuscular electrical stimulation (NMES). Both devices use electric impulses that generated by an electric pulse generator to conduct thru skin contact electrodes onto the abdominal muscle region of the patient to achieve muscles conditioning. The electric muscles stimulation (EMS) mode of the Gymform Dual Flex Belt and the Slendertone FLEX Abdominal Training System Type 515 (K030708)use the totally-enclosed concept that electrodes are wrapped by the flex belt connected to the studs of its electric pulse signal generator built inside the flex belt, become an integral part; such design eliminates the use of external lead wires/patient cables for conductivity needs, helps to prevent undesired interference to the electrodes when operating. For the most part, chances of misuse are substantially reduced as electrodes are pre-positioned in the flex belt restricted to use only on the patient's abdominal region.

7. Key Technological characteristics comparison:

Chart below compares the spec sheet between the Gymform Dual Flex Belt and the Slendertone FLEX Abdominal Training System Type 515 (K030708):

Primary parameters	Gymform DualFlex Belt WB-162(500Ω load eachchannel)	Slendertone FLEXAbdominal TrainingSystem Type 515(500Ω load eachchannel)
Number of channels	Single	Dual
Waveform	Symmetrical Biphasic	Symmetrical Biphasic
Output frequency (Hz)	14/18/25/28/33	45 - 75
Positive pulse width (us)	230	200 - 300
Negative pulse width (us)	230	200 - 300
Number of programs	5	7
Program duration (min)	20, 21, 22 & 24	20,25 & 30
Max intensity levels each program	30	99
Power source	12V AC Adapter	3x 1.5V AAA Batteries

The Gymform Dual Flex Belt output is different from Slendertone FLEX Abdominal Training System Type 515, but both devices comply with FDA safety requirements and comply with

[05-1-3] Revised March 12 2012

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Image /page/3/Picture/1 description: The image shows a logo with a stylized "WB" on the left and the text "Wall Brain International LTD." above the text "
翊盛國際有限公司" on the right. The text on the right is smaller than the logo on the left. The logo is in black and white.

510(k) Summary of Safety and Effectiveness This summary is submitted in accordance with 21 CFR 807.92

safety standard IEC 60601-2-10. Moreover, the effectiveness test report of Gymform Dual Flex Belt demonstrates that the new device has same effectiveness of predicate device.

8. Non-clinical Studies:

Testing of the Gymform Dual Flex Belt for the conformity of recognized consensus standards that outlined below has been successfully performed to assure of safety and efficacy.

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2. Medical Electrical Equipment Part 1-2: General Requirements . for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment Part 2-. 10: Particular requirements for the safety of nerve and muscle stimulators.
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In . Vitro cytotoxicity.
ISO 10993-10:2002, Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity.

Substantial equivalence: ರು.

The electric muscles stimulation (EMS) mode of the Gymform Dual Flex Belt and the Slendertone FLEX Abdominal Training System Type 515 (K030708) are designed, developed and built on the identical technology of electrical muscle stimulation whereby technological characteristics and applications are acquired. Although to some degree there are differences in product specifications, verification and validation tests demonstrated the Gymform Dual Flex Belt maintains same safety and effectiveness as that of the cleared predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708). More importantly, the electric muscles stimulation (EMS) mode of the Gymform Dual Flex Belt (new device) is indicated for use on abdominal muscles conditioning which is essentially identical to the predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708) that legally marketed in the United States.

Conclusion:

There are unlikely any significant differences existing between the electric muscles stimulation (EMS) mode of the Gymform Dual Flex Belt (new device) and the Slendertone FLEX Abdominal Training System Type 515 (K030708), and should not raise any new issues of safety and effectiveness.

[05-1-4] Revised March 12 2012

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Well Brain International, Limited % Mr. Victor K. Wai Managing Director Room 1212 Harbour Crystal Centre 100 Granville Road Tsim Sha Tsui East, Kowloon Hong Kong SAR, China

Re: K111781

Trade/Device Name: Gymform Dual Flex Belt Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX, IRO Dated: July 09, 2012 Received: July 09, 2012

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

JUL 1 1 2012

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson na
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows a logo for Well Brain International LTD. The logo consists of three thick, black, vertical lines that are slightly curved and angled towards the right. To the right of the lines is a black circle, and further to the right is the text "Well Brain International LTD." written in a smaller font. Below this text is another line of text in a different language, possibly Chinese, with the characters appearing more complex and compact.

(04) Indications for Use Statement

510(k) Number (To be assigned)

Device Name: Gymform Dual Flex Belt

Indication for Use:

The electrical muscle stimulation (EMS) operation mode is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.

The therapeutic vibrator (Vibration) operation mode is indicated for the promotion of muscle relaxation.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (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)

(Division Sign-off) Division of Surgical, Orthopedic, And Restorative Devices

510(k) Number K111781

[04-1-1]
Revised December 12 2011

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).