Cleared Traditional

GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

K032719 · Gemore Technology Co, Ltd. · Neurology

Dec 2003

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K032719 is an FDA 510(k) clearance for the GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING), a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Gemore Technology Co, Ltd. (Tan Shui, Taipei Hsien, TW). The FDA issued a Cleared decision on December 10, 2003, 99 days after receiving the submission on September 2, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K032719 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2003
Decision Date	December 10, 2003
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF