Cleared Traditional

MCCONNELL SHOULDER BRACE

K910974 · Mcconnell Orthopedic · Physical Medicine
Mar 1991
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K910974 is an FDA 510(k) clearance for the MCCONNELL SHOULDER BRACE, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Mcconnell Orthopedic (Dallas, US). The FDA issued a Cleared decision on March 21, 1991, 14 days after receiving the submission on March 7, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K910974 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1991
Decision Date March 21, 1991
Days to Decision 14 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