Cleared Special

MODIFICATION TO: WINNER ST-2 STIMULATOR

K013770 · Rich-Mar Corp. · Physical Medicine
Jan 2002
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K013770 is an FDA 510(k) clearance for the MODIFICATION TO: WINNER ST-2 STIMULATOR, 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 January 18, 2002, 66 days after receiving the submission on November 13, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K013770 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2001
Decision Date January 18, 2002
Days to Decision 66 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850