StimOnTM Pain Relief System (GM2439)

Stimulator, Nerve, Transcutaneous, For Pain Relief

Gimer Medical Co., Ltd.

The following data is part of a premarket notification filed by Gimer Medical Co., Ltd. with the FDA for Stimontm Pain Relief System (gm2439).

Pre-market Notification Details

Device IDK213802
510k NumberK213802
Device Name:StimOnTM Pain Relief System (GM2439)
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Gimer Medical Co., Ltd. 9F.-5 And 9F.-8, No. 97, Sec. 1, Xintai 5th Road, Xizhi District New Taipei City,  TW 22175
ContactRex Chang
CorrespondentAnita Chen
ZhengCheng Limited Company 238 No.19. 335 Lane, Fu-Xi Road, Shulin District New Taipei City,  TW 238
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-06
Decision Date2022-08-26

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