Device Information - Geniuschip Fitness Belt

Sponsor: Company Name: Hong Qiang Xing (Shenzhen) Electronics LimitedAddress: 4F., Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Baoan District, Shenzhen, Guangdong Province, PRCPhone: 86-755-26423615 Fax No.: 86-755-29915485-818Contact Person (including title): Mr. Xu Jianhua (General Manager)E-mail: infosunmas.comSubject Device:Device Common Name: Powered muscle stimulatorTrade Name: Fitness Belt, Model: SM9065Regulation Number: 21 CFR 890.5850Regulation Name / Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Regulatory Class: 2Product Code: NGXIntended Use / Indications for Use:The SUNMAS Fitness Belt is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It may be considered as a technique or method for muscle training.The big belt is intended for use on the muscles in abdomen.The small belt is intended for use on the muscles in arms and thighs areas.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.Indication 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.ChannelDual channels (Isolated between two channels)Number of programs8 programs (modes)Number of phases variations28 (See below “Mode Specification Table” for detail.)Number of adjustable independent outputs2CurrentFrom 0 to 60 mA (From 0 to 1000 Ohm)Frequency range8.5 to 64 Hz Pulse width range220 usContraction and Relaxation timeAdjustable, due to different modes.(See below “Mode Specification Table” for detail.)Power2 X 1.5V AAA batteriesSize82mm (L) X 62mm (W) X 23mm (H)Weight81.2g (with battery)Treatment TimeDefault time is 10 minutes, minimum time is 5, and maximum time is 45 minutes.LCD display informationIndicate the following information: Sound on/off, Keylock, Low battery, Channel indication (electrodes contact detection of two channels), Intensity level, Mode selection. Battery lifeApproximately 25 hours at nominal settingsEnvironment for operatingTemperature: 5 40 CHumidity: 20 65% RHEnvironment for storageTemperature: 0 40 CHumidity: 10 90% RHConnection device for belt and control unitWires plug 2mm malePredicate Device 2:510(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.ChannelDual channelsNumber of programs4 programs (modes)Number of adjustable independent outputs2CurrentFrom 0 to 70 mA (From 0 to 1000 Ohm)Frequency range50 to 70 Hz Pulse width range200 usPower3x 1,5 V alkaline batteries type LR6/AA (not provided)Device Dimensions69 x 43 x 87 (h) mmWeight106 g (without battery)Treatment TimeAbout 4 min 30 secLCD display informationIndicate the following information: indicator of power, indicator of electrodes or of contact, indicator of weak and/or defective battery, indicator absence contact belt, indicator of the programs. Environment for operatingTemperature: 5 45 CHumidity: 20 65% RHEnvironment for storageTemperature: 0 45 CHumidity: 10 90% RHConnection device for belt and control unitWires plug 2mm maleGuarantee2 yearsBelt Size(unisex)From 34 cm to 60 cmLength of the unfolded belt49.6 Inch/126 cmBelt Pads432 cm2Panty Pads425 cm2ClassificationType BFSpecification:Power Source2 x 1.5V AAA batteriesPatient leakage currentComply with IEC 60601-1 and IEC 60601-2-10Stimulated musclesAbdomen, arms and thighsNumber of channelsTwo channelsNumber of programsSix modesOutputFrom 0 V to 90 VOutput intensity level10 level Frequency150 HzPulse width range200 us (Constant)Contraction and relaxation timeAdjustable, due to different modes. (See below “Program Specification Table”)Treatment time30 minutes (default)Indicator displayIndicate the following information: modes, intensity & frequency levels and time.Electrode size Small (one piece): about 56.7 cm2 ;Big (one piece): about 96.04 cm2Control unit dimension106.6 mm (L) X 77.9 mm (W) X 31.3 mm (H)WeightControl unit (except for batteries): 83 gBig belt: 84 gSmall belt: 49 g x 2 pieceElectrode pad (big): 22 g Electrode pad (small): 14 g x 6 pieceEnvironment for operationTemperature: 540 CHumidity: 80% RHEnvironment for storageTemperature: 045 CHumidity: 93% RHProgram Specification Table Output SpecificationNote: Frequency Grade 110 is expressed to be FRE1 FRE10.Mode 1Short Rhythmic CrunchBasic WaveformCycle Waveform Mode 2 Medium Rhythmic CrunchBasic WaveformCycle WaveformMode 3 Rolling Massage WaveBasic WaveformCycle WaveformMode 4 Long Massage WaveBasic WaveformCycle WaveformMode 5 Rolling Penetrating PulseBasic WaveformCycle WaveformMode 6 Long Penetrating PulseBasic WaveformCycle WaveformLabel：SYMBOLSMEANSSYMBOLSMEANSManufacturerAuthorized representative in the European CommunityRe-back labelType BF Applied PartAttention, consult Instruction for UseDevice description:SUNMAS Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of an electronic stimulator module for signal generation, three belts for fixation, and series electrodes.The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.Power is derived from 2 “AAA” batteries located in a compartment protected by a removable battery cover. 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 and frequency level can be adjusted by user.StandardStandard TitleLocationIEC 60601-1Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995VOL_009_Attachment 7.IEC 60601-2-10Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators, 1987+A1:2001VOL_009_Attachment 7.IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007VOL_009_Attachment 7.ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009VOL_009_Attachment 7.ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity, 2010VOL_009_Attachment 7.Elements of ComparisonSubject DevicePredicate DeviceRemarkDevice Name and ModelSM9065 Fitness Belt, Model: SM9065X2ABS Dual Channel Fitness BeltSPORT-ELEC Body Control System 4M-510 (K) NumberApplyingK102295K092476-Intended UseThe SUNMAS Fitness Belt is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It may be considered as a technique or method for muscle training.The big belt is intended for use on the muscles in abdomen.The small belt is intended for use on the muscles in arms and thighs areas.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 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.SENote 1SpecificationChannelTwo channelsTwo channelsTwo ChannelsSENumber of programs6 programs8 programs4 programsSENote 2Output intensity level10 steps28 steps-SENote 2Output voltage/currentFrom 0 to 90 VFrom 0 to 60 mAFrom 0 to 70 mA (From 0 to 1000 Ohm)SENote 3Waveform frequency range1 to 50 Hz8.5 to 64 Hz50 to 70 HzSENote 3Minimum pulse width200 s (Constant)220 s (Constant) 200 s (Constant)SENote 3Contraction and Relaxation timeAdjusted by FRE-UP and FRE-DOWN buttons, due to different frequencies.Adjustable, due to different modes.Adjustable, due to different modes.SEPower2 x 1.5V AAA batteries2 x 1.5V AAA batteries3 x 1.5V AA batteriesSENote 4Electrode SizeSmall: about 56.7 cm2;Big: about 96.04 cm232 cm2Small: 25 cm2Big: 32 cm2SENote 5Maximum Current Density1.010-4 (mA/cm2) (for the smallest size electrode about 56.7 cm2)0.032 mA/cm2 500(for the smallest size electrode 32.0 cm2)-SENote 5Timer RangeDefault time is 30 minutesDefault time is 10 minutes, minimum time is 5 minutes-SELCD displayIndicate the following information: modes, intensity & frequency levels and time.Indicate the following information: Sound on/off, Keylock, Low battery, Channel indication, Intensity level, Mode selection.Indicate the following information: indicator of power, indicator of electrodes or of contact, indicator of weak and/or defective battery, indicator absence contact belt, indicator of the programs.SEEnvironment for operatingTemperature: 5 40 CHumidity: 80% RHTemperature: 5 40 CHumidity: 20 65% RHTemperature: 5 45 CHumidity: 20 65% RHSENote 4Environment for storageTemperature: 0 45 CHumidity: 93% RHTemperature: 0 40 CHumidity: 10 90% RHTemperature: 0 45 CHumidity: 10 90% RHSENote 4StandardsBiocompatibilityAll 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.SEElectrical SafetyComply with IEC 60601-1 and IEC 60601-2-10Comply with IEC 60601-1 and IEC 60601-2-10Comply with IEC 60601-1 and IEC 60601-2-10SEEMCComply with IEC 60601-1-2Comply with IEC 60601-1-2Comply with IEC 60601-1-2SEComparison 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 devices can also be used on the same muscles according to the device description of 510(k) summary. So the subject device and predicate devices have the same intended use aspect.Note 2:Although the “Number of programs”, and “Output intensity level” of subject device are different from the predicate devices, they are all compliance with IEC 60601-1 and 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 voltage/current”, “Waveform frequency range” and “Minimum Pulse width” 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 specification 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 specification will not raise any safety or effectiveness issue. 附上负责人手写签名图片The electrode used in the subject device is purchased from other manufacturer, whose product K number is K070612.All electrodes used in the device are Top-Rank adhesive electrode (manufactured by Top-Rank Health Care Equipment Co., Ltd.), which is cleared by FDA.