OTC PATCH

Stimulator, Nerve, Transcutaneous, Over-the-counter

WELL-LIFE HEALTHCARE LIMITED

The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Patch.

Pre-market Notification Details

Device IDK133723
510k NumberK133723
Device Name:OTC PATCH
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County,  TW 234
ContactChin-chin Hsieh
CorrespondentChin-chin Hsieh
WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County,  TW 234
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-06
Decision Date2014-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20050428514454 K133723 000
04719872264064 K133723 000

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