WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A

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 Well Life Wireless Tens/ems Stimulator, Models Wr-2605/2605a.

Pre-market Notification Details

Device IDK161453
510k NumberK161453
Device Name:WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant WELL-LIFE HEALTHCARE LIMITED 1F, NO.16, LANE 454 JUNGJENG ROAD Yunghe City, Taipei County,  TW 234
ContactChin-chih Hsieh
CorrespondentChin-chih Hsieh
WELL-LIFE HEALTHCARE LIMITED 1F, NO.16, LANE 454 JUNGJENG ROAD Yunghe City, Taipei County,  TW 234
Product CodeNUH  
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-26
Decision Date2016-12-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20856675008056 K161453 000
00856675008007 K161453 000
10853635002447 K161453 000
00853635002433 K161453 000
04719872266051 K161453 000
00856675008755 K161453 000
00856675008724 K161453 000

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