Cleared Traditional

RICH-MAR IFV 1000

K914539 · Rich-Mar Corp. · Physical Medicine
Dec 1991
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K914539 is an FDA 510(k) clearance for the RICH-MAR IFV 1000, 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 18, 1991, 68 days after receiving the submission on October 11, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K914539 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1991
Decision Date December 18, 1991
Days to Decision 68 days
Submission Type Traditional
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