Cleared Traditional

K820051 - OBUS FORME ORTHOPEDIC BRACE, UPRIGHT
(FDA 510(k) Clearance)

K820051 · Obus Forme, Ltd. · Physical Medicine
Jan 1982
Decision
21d
Days
Class 1
Risk

K820051 is an FDA 510(k) clearance for the OBUS FORME ORTHOPEDIC BRACE, UPRIGHT. This device is classified as a Orthosis, Lumbar (Class I — General Controls, product code IQE).

Submitted by Obus Forme, Ltd. (Walker, US). The FDA issued a Cleared decision on January 29, 1982, 21 days after receiving the submission on January 8, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number K820051 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1982
Decision Date January 29, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IQE — Orthosis, Lumbar
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3490