ACU-STIM TENS, AP-101082T

Stimulator, Nerve, Transcutaneous, For Pain Relief

APEX MEDICAL CORP.

The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Acu-stim Tens, Ap-101082t.

Pre-market Notification Details

Device IDK973980
510k NumberK973980
Device Name:ACU-STIM TENS, AP-101082T
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien,  TW
ContactDaniel Lee
CorrespondentDaniel Lee
APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien,  TW
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-20
Decision Date1998-07-29

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