Cleared Traditional

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

K032994 · Gemore Technology Co, Ltd. · Neurology

Dec 2003

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K032994 is an FDA 510(k) clearance for the GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Gemore Technology Co, Ltd. (Tan Shui, Taipei Hsien, TW). The FDA issued a Cleared decision on December 16, 2003, 82 days after receiving the submission on September 25, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K032994 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2003
Decision Date	December 16, 2003
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF