Cleared Traditional

K810450 - TRUNCAL ORTHOSIS
(FDA 510(k) Clearance)

K810450 · Fred Sammons, Inc. · Physical Medicine
Mar 1981
Decision
13d
Days
Class 1
Risk

K810450 is an FDA 510(k) clearance for the TRUNCAL ORTHOSIS. This device is classified as a Orthosis, Lumbar (Class I — General Controls, product code IQE).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981, 13 days after receiving the submission on February 19, 1981.

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

Submission Details

510(k) Number K810450 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1981
Decision Date March 04, 1981
Days to Decision 13 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