Cleared Traditional

IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT

K893994 · Rich-Mar Corp. · Physical Medicine
Dec 1989
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K893994 is an FDA 510(k) clearance for the IF2000 ELECTRICAL MUSCLE STIMULATOR 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 December 14, 1989, 192 days after receiving the submission on June 5, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K893994 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1989
Decision Date December 14, 1989
Days to Decision 192 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