Cleared Traditional

HEAD HALTER

K830245 · Warm & Form, Orthopedic Materials · Physical Medicine
Mar 1983
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K830245 is an FDA 510(k) clearance for the HEAD HALTER, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 43 days after receiving the submission on January 25, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5925.

Submission Details

510(k) Number K830245 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date March 09, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILZ — Accessories, Traction
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5925