Cleared Traditional

BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

K031375 · Besmed Health Business Corp · Physical Medicine

Nov 2003

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K031375 is an FDA 510(k) clearance for the BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 20, 2003, 204 days after receiving the submission on April 30, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K031375 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2003
Decision Date	November 20, 2003
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement