Cleared Traditional

GAIT-AID ORTHOPEDIC INSOLE

K874502 · Gait-Aid, Inc. · Physical Medicine
Nov 1987
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K874502 is an FDA 510(k) clearance for the GAIT-AID ORTHOPEDIC INSOLE, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Gait-Aid, Inc. (Ontario, Canada, CA). The FDA issued a Cleared decision on November 30, 1987, 28 days after receiving the submission on November 2, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K874502 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1987
Decision Date November 30, 1987
Days to Decision 28 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