Cleared Traditional

ADJUSTABLE POLYCENTRIC ELBOW HINGE

K831542 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K831542 is an FDA 510(k) clearance for the ADJUSTABLE POLYCENTRIC ELBOW HINGE, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 43 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K831542 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 24, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

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