GEM-STIM TENS, MODELS GM3XY AND GM3AXY— 510(k) K032720

Name: FDA 510(k) clearance K032720
Creator: U.S. Food and Drug Administration
Published: 2003-12-10

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K032720 for GEM-STIM TENS, MODELS GM3XY AND GM3AXY, Substantially Equivalent on 2003-12-10. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant: Gemore Technology Co, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2003-09-02
Decision date: 2003-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tan Shui, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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