GIM-STIM OTC TENS/EMS System— 510(k) K190988

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K190988 for GIM-STIM OTC TENS/EMS System, Substantially Equivalent on 2019-08-16. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant
Gemore Technology Co, Ltd.
Product code
Code NUH
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tan Shui, New Taipei City, TW
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