Cleared Traditional

K823635 - CUSHIONS FOR WHEELCHAIR ARMS
(FDA 510(k) Clearance)

K823635 · Fred Sammons, Inc. · Physical Medicine device

Dec 1982

Decision

22d

Days

Class 1

Risk

K823635 is an FDA 510(k) clearance for the CUSHIONS FOR WHEELCHAIR ARMS. This device is classified as a Accessories, Wheelchair (Class I - General Controls, product code KNO).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 22 days after receiving the submission on December 6, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3910.

Submission Details

510(k) Number	K823635 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 06, 1982
Decision Date	December 28, 1982
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—