Cleared Special

AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

K032941 · Rich-Mar Corp. · Physical Medicine

Oct 2003

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K032941 is an FDA 510(k) clearance for the AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on October 22, 2003, 30 days after receiving the submission on September 22, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K032941 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2003
Decision Date	October 22, 2003
Days to Decision	30 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Statement