Sponsor:SlinphTechnologiesCo.,LTD
SubjectDevice:iHelmetHairGrowthSystem,Model:LTD200S
FileNo.:510(k)submissionreport(V1.0),Chapter6
Note2:
Althoughthe“Weight”,“Dimensions”,“EnvironmentforOperation”,“EnvironmentforStorage”of
subjectdevicearedifferentfromthepredicatedevice,itwillnotaffectthemainfunctionandthe
intendeduseofthedeviceastheyallalsocomplywithIEC60601-1requirements.Besides,thesubtle
changesofthephysicalcharacteristicswillnotaffectthecriticalfunctionsorthenormaluse.
8.Conclusion
ThesubjectdeviceiHelmetHairGrowthSystemhasallfeaturesofthepredicatedevices.Thefew
differencesdonotaffectthesafetyandeffectivenessofthesubjectdevice.Thus,thesubject
deviceissubstantiallyequivalenttothepredicatedevices.
9.SummaryPreparedDate
2April2017
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