Cleared Traditional

FLEXION DISTRATION SUPPORT

K921711 · Altoona Medical Supply · Physical Medicine
Jul 1992
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K921711 is an FDA 510(k) clearance for the FLEXION DISTRATION SUPPORT, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Altoona Medical Supply (Altoona, US). The FDA issued a Cleared decision on July 13, 1992, 96 days after receiving the submission on April 8, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5925.

Submission Details

510(k) Number K921711 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1992
Decision Date July 13, 1992
Days to Decision 96 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILZ — Accessories, Traction
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5925