Cleared Traditional

ACCUFLEX DYNAMIC ELBOW ORTHOSIS

K926391 · Regulatory & Marketing Services, Inc. · Physical Medicine
Jul 1993
Decision
213d
Days
Class 1
Risk

About This 510(k) Submission

K926391 is an FDA 510(k) clearance for the ACCUFLEX DYNAMIC ELBOW ORTHOSIS, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on July 22, 1993, 213 days after receiving the submission on December 21, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K926391 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1992
Decision Date July 22, 1993
Days to Decision 213 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IQI — Orthosis, Limb Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475