Cleared Traditional

RICH-MAR HV 1000 MUSCLE STIMULATOR

K920833 · Rich-Mar Corp. · Physical Medicine
May 1992
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K920833 is an FDA 510(k) clearance for the RICH-MAR HV 1000 MUSCLE 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 May 22, 1992, 87 days after receiving the submission on February 25, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K920833 FDA.gov
FDA Decision Cleared SN
Date Received February 25, 1992
Decision Date May 22, 1992
Days to Decision 87 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