Cleared Traditional

OB HELP ARM

K830842 · Lic-Orthion · Physical Medicine
Apr 1983
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K830842 is an FDA 510(k) clearance for the OB HELP ARM, a Sling, Arm, Overhead Supported (Class I — General Controls, product code ILE), submitted by Lic-Orthion (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 19 days after receiving the submission on March 17, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K830842 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1983
Decision Date April 05, 1983
Days to Decision 19 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILE — Sling, Arm, Overhead Supported
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475