Cleared Traditional

K812099 - CASH ORTHOSIS
(FDA 510(k) Clearance)

K812099 · David Hendricks, C.P.O. · Physical Medicine device

Aug 1981

Decision

20d

Days

Class 1

Risk

K812099 is an FDA 510(k) clearance for the CASH ORTHOSIS. This device is classified as a Orthosis, Lumbo-sacral (Class I - General Controls, product code IPY).

Submitted by David Hendricks, C.P.O. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 20 days after receiving the submission on July 24, 1981.

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

Submission Details

510(k) Number	K812099 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 1981
Decision Date	August 13, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—