Cleared Traditional

RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE

K000808 · Rich-Mar Corp. · Physical Medicine

Aug 2000

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K000808 is an FDA 510(k) clearance for the RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS 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 August 25, 2000, 165 days after receiving the submission on March 13, 2000. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K000808 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2000
Decision Date	August 25, 2000
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement