Cleared Traditional

K823595 - HEAD SUPPORT FOR WHEELCHAIR
(FDA 510(k) Clearance)

K823595 · Fred Sammons, Inc. · Physical Medicine device

Dec 1982

Decision

16d

Days

Class 1

Risk

K823595 is an FDA 510(k) clearance for the HEAD SUPPORT FOR WHEELCHAIR. 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 22, 1982, 16 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	K823595 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 06, 1982
Decision Date	December 22, 1982
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—