FitRelief TENS&EMS Wireless Device

Stimulator, Muscle, Powered, For Muscle Conditioning

Heat In A Click LLC.

The following data is part of a premarket notification filed by Heat In A Click Llc. with the FDA for Fitrelief Tens&ems Wireless Device.

Pre-market Notification Details

Device IDK191938
510k NumberK191938
Device Name:FitRelief TENS&EMS Wireless Device
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Heat In A Click LLC. 1975 Tigertail Blvd Dania,  FL  33004
ContactGuy Levi
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510006
Product CodeNGX  
Subsequent Product CodeNFO
Subsequent Product CodeNUH
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-19
Decision Date2020-08-28

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