Device Information - Well Brain Fitness Belt

Sponsor: Name: Well Brain International Ltd.Address: Rm. 1212, 12 Floor, Harbour Crystal Centre, No. 100 Granville Road, Tsim Sha Tsui East, Kowloon, Hong Kong SAR, ChinaEstablishment registration number: 3004950644Contact name: Victor K WaiTitle: Managing DirectorTel: (852) 2619-0833Fax: (852) 2429-0960E-mail: victorwellbrain-intl.comManufacturing site relating to this submission:Well Brain International Ltd.Address: B19-B20 Zone One, Xicheng Hi Tech Zone Hengli Town, Dongguan City, Guangdong Province, China Postal Code 523460Tel: +86-769-81180888Fax: +86-769-82301111Subject Device:Device Common Name: Powered muscle stimulatorTrade Name: GYMFORM ABS-A-ROUND, Model: VDPGYCIND0016Regulation Number: 21 CFR 890.5850Regulation Name / Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Regulatory Class: 2Product Code: NGXIntended 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 4-area belt is intended for use on the muscles in abdomen, left side of waist and right side of waist alternately.The Mini belt is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.Predicate Device 1:510(K) Number: K102295Company Name: Red Lemon IncorporationAddress: 19/F, Nan Dao Commercial Bldg, 359-361 Queens Road Central, Hong Kong, ChinaTrade/Device Name: X2ABS Dual Channel Fitness BeltRegulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use: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.Indications for Use:The X2ABS Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.Contraindicated use on injured or otherwise impaired muscles.Not intended for use in any therapy or for the treatment of any medical conditions or diseases.Predicate Device 2:510(K) Number: K111781Company Name: Well Brain International Ltd.Address: 1814 North Tower, Concordia Plaza, 1 Science Museum Road, TST Kowloon, Hong Kong SAR, ChinaTrade/Device Name: Gymform Dual flex belt, Model: WB-162Regulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use: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) 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.Predicate Device 3:510(K) Number: K111476Company Name: Contour TechnologyTrade/Device Name: Contour Technology Muscle Stimulator, Model: MX9Regulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use / Indications for Use: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 intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.The Contour Technology Muscle Stimulator Back Pad accessory is intended for use on the lower back muscles only.Predicate Device 4:510(K) Number: K122744Company Name: Prospera CorporationTrade/Device Name: Prospera OTC TENS Electronic Pulse MassagerModels: PL, 009Regulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use / Indications for Use: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.Predicate Device 5:510(K) Number: K092476Company Name: SPORT-ELEC S.A.Trade/Device Name: SPORT-ELEC Body Control System 4MRegulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use / Indications for Use:The Body Control -4M 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 and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.Predicate Device 6:510(K) Number: K011880Company Name: COMPEX SATrade/Device Name: COMPEXSPORTRegulation Number: 21 CFR 890.5850Regulatory Class: 2Product Code: NGXIntended Use / Indications for Use:The “Compex Sport” is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the “Compex Sport” training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.The “Compex Sport” electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations).These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.The various types of muscle work that the “Compex Sport” can impose on the stimulated muscles are able to improve or facilitate muscle performance.The “Compex Sport” may therefore be considered a technique of muscle training.Specification:Power Source3 x 1.5V AAA batteriesPatient leakage currentComply with IEC 60601-1 and IEC 60601-2-10Stimulated musclesAbdomen, left side of waist, right side of waist, arms, legs, thighs and buttocksNumber of channels3 channels (Alternating)Number of programs6 programs (See below “Program Specification Table” for detail.)OutputFrom 0 to 118 V (From 0 to 1000 Ohm)Output Intensity Level99 stepsFrequency2 Hz, 10 Hz, 50 Hz, 90 Hz, 120 HzPulse width range100 us / 120 usContraction and Relaxation timeAdjustable, due to different modes. (See below “Program Specification Table”)Timer RangeDefault time (maximum) is 19 minutes.Indicator DisplayIndicate the following information: Power on/off, Channel indication, low battery, Intensity level, Program selection.Maximum duration of Electrode pads160 times for small electrode pads and 190 times for big onesElectrode SizeSmall: 33.0 cm x 1 pieceBig: 34.5 cm x 2 piecesControl unit weight (Without batteries)70gThe weight of accessoriesBig belt: 310gSmall belt: 25gElectrode pad (big): 40gElectrode pad (small): 26gControl unit dimension91.8 mm(L) X 25.5 mm (W) X 82 mm (H)Environment for operationTemperature: 5 45 CHumidity: 20 65% RHEnvironment for storageTemperature: 0 45 CHumidity: 10 90% RHProgram Specification TableOutput SpecificationMode 1Mode 2Mode 3Mode 4Front 90s:Back 90s:Mode 5Mode 6Rating Input: 4.5Vdc (1.5V “AAA” battery x 3), 3WDevice 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 side of waist and right side of waist alternately.The Mini belt 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.StandardStandard TitleLocationIEC 60601-1Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995Attachment 7IEC 60601-2-10Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators, 1987+A1:2001Attachment 7IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007Attachment 7ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009N/AISO 10993-10Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1:2006N/AUpdate:The differences between the revised sample and original sample are as below list:1) Removing the electrodes of lower back from 4-area belt. 2) The output channels symbols “S” and “B” were renamed to “L” and “R”. The right waist belt was changed to be powered by “R” channel. And “L” channel is only connected to the left waist belt.For above modification, leakage current test and humidity preconditioning treatment test were re-conducted.The Channel Symbol and Intensity Value will flash when the output is active.