Perfect EMS

Stimulator, Nerve, Transcutaneous, Over-the-counter

TensCare Ltd.

The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Perfect Ems.

Pre-market Notification Details

Device IDK200694
510k NumberK200694
Device Name:Perfect EMS
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant TensCare Ltd. 9 Blenheim Road, Longmead Business Park Epsom,  GB Kt19 9be
ContactAndrew Brown
CorrespondentAndrew Brown
TensCare Ltd. 9 Blenheim Road, Longmead Business Park, Epsom,  GB Kt19 9be
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-17
Decision Date2021-06-04

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