Cleared Traditional

ROTATION BOOT

K823665 · Warm & Form, Orthopedic Materials · Physical Medicine
Dec 1982
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K823665 is an FDA 510(k) clearance for the ROTATION BOOT, a Orthosis, Corrective Shoe (Class I — General Controls, product code KNP), submitted by Warm & Form, Orthopedic Materials (Walker, US). The FDA issued a Cleared decision on December 30, 1982, 24 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K823665 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date December 30, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code KNP — Orthosis, Corrective Shoe
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475