MSLS6QF TENS/PMS Device

Stimulator, Nerve, Transcutaneous, Over-the-counter

Self Doctor Care, LLC

The following data is part of a premarket notification filed by Self Doctor Care, Llc with the FDA for Msls6qf Tens/pms Device.

Pre-market Notification Details

Device IDK193655
510k NumberK193655
Device Name:MSLS6QF TENS/PMS Device
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Self Doctor Care, LLC 8811 Teel Pkwy Ste 100, Unit 6141 Frisco,  TX  75036
ContactWei Wei
CorrespondentWei Wei
Self Doctor Care, LLC 8811 Teel Pkwy Ste 100, Unit 6141 Frisco,  TX  75036
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-09-04

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