Cleared Traditional

AIRCAST PNEUMATIC KNEE BRACE

K812094 · Aircast, Inc. · Physical Medicine
Aug 1981
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K812094 is an FDA 510(k) clearance for the AIRCAST PNEUMATIC KNEE BRACE, a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Aircast, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 20 days after receiving the submission on July 24, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K812094 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1981
Decision Date August 13, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ITQ — Joint, Knee, External Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475

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