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510(k) Data Aggregation
K Number
K142055Device Name
GYMFORM ABS & CORE
Manufacturer
WELL BRAIN INTERNATIONAL, LTD.
Date Cleared
2015-05-11
(286 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
WELL BRAIN INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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.
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.
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K Number
K130074Device Name
GYMFORM ABS-A-ROUND
Manufacturer
WELL BRAIN INTERNATIONAL, LTD.
Date Cleared
2013-08-15
(213 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
WELL BRAIN INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K111781Device Name
GYMFORM DUAL FLEX BELT MODEL WB-162
Manufacturer
WELL BRAIN INTERNATIONAL, LTD.
Date Cleared
2012-07-11
(383 days)
Product Code
NGX, IRO
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
WELL BRAIN INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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.
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