Cleared Traditional

ARTROMOT MULTI DIRECTIONAL ANKLE CPM

K924484 · Buckman Co., Inc. · Physical Medicine
Mar 1993
Decision
200d
Days
Class 1
Risk

About This 510(k) Submission

K924484 is an FDA 510(k) clearance for the ARTROMOT MULTI DIRECTIONAL ANKLE CPM, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on March 22, 1993, 200 days after receiving the submission on September 3, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K924484 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1992
Decision Date March 22, 1993
Days to Decision 200 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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