Cleared Traditional

K823816 - WHEELCHAIR PATIENT RESTRAINTS
(FDA 510(k) Clearance)

K823816 · Danek Medical, Inc. · Physical Medicine device

Jan 1983

Decision

28d

Days

Class 1

Risk

K823816 is an FDA 510(k) clearance for the WHEELCHAIR PATIENT RESTRAINTS. This device is classified as a Accessories, Wheelchair (Class I - General Controls, product code KNO).

Submitted by Danek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983, 28 days after receiving the submission on December 17, 1982.

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

Submission Details

510(k) Number	K823816 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 1982
Decision Date	January 14, 1983
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—