Cleared Traditional

RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT

K901779 · Rich-Mar Corp. · Physical Medicine
Jun 1990
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K901779 is an FDA 510(k) clearance for the RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT, 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 June 26, 1990, 70 days after receiving the submission on April 17, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K901779 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1990
Decision Date June 26, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

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