Cleared Traditional

ARTROMOT SB ELBOW ATTACHMENT

K923857 · Buckman Co., Inc. · Physical Medicine
Feb 1993
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K923857 is an FDA 510(k) clearance for the ARTROMOT SB ELBOW ATTACHMENT, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on February 12, 1993, 196 days after receiving the submission on July 31, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K923857 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1992
Decision Date February 12, 1993
Days to Decision 196 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