Cleared Traditional

K761128 - LATERAL TRUNK SUPPORTS
(FDA 510(k) Clearance)

K761128 · Fred Sammons, Inc. · Physical Medicine device

Dec 1976

Decision

13d

Days

Class 1

Risk

K761128 is an FDA 510(k) clearance for the LATERAL TRUNK SUPPORTS. This device is classified as a Orthosis, Thoracic (Class I - General Controls, product code IPT).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976, 13 days after receiving the submission on November 19, 1976.

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

Submission Details

510(k) Number	K761128 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 19, 1976
Decision Date	December 02, 1976
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—