Cleared Traditional

RICH-MAR CONDUCTIVE GEL II W/ALOE VERA

K890147 · Rich-Mar Corp. · Physical Medicine
Mar 1989
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K890147 is an FDA 510(k) clearance for the RICH-MAR CONDUCTIVE GEL II W/ALOE VERA, 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 March 23, 1989, 69 days after receiving the submission on January 13, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K890147 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1989
Decision Date March 23, 1989
Days to Decision 69 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