Cleared Traditional

ARTROMOT K2 CPM

K931555 · Ormed Mfg., Inc. · Physical Medicine
Jan 1994
Decision
307d
Days
Class 1
Risk

About This 510(k) Submission

K931555 is an FDA 510(k) clearance for the ARTROMOT K2 CPM, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Ormed Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on January 31, 1994, 307 days after receiving the submission on March 30, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K931555 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1993
Decision Date January 31, 1994
Days to Decision 307 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code BXB — Exerciser, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380