Cleared Traditional

ABDUCTION PILLOW

K830243 · Warm & Form, Orthopedic Materials · Physical Medicine
Mar 1983
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K830243 is an FDA 510(k) clearance for the ABDUCTION PILLOW, a Splint, Abduction, Congenital Hip Dislocation (Class I — General Controls, product code IOZ), submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on March 8, 1983, 42 days after receiving the submission on January 25, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3665.

Submission Details

510(k) Number K830243 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date March 08, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOZ — Splint, Abduction, Congenital Hip Dislocation
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3665