Cleared Traditional

K922772 - TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
(FDA 510(k) Clearance)

K922772 · Biodan Medical Systems, Ltd. · Physical Medicine device

Jul 1992

Decision

34d

Days

Class 2

Risk

K922772 is an FDA 510(k) clearance for the TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR. This device is classified as a System, Isokinetic Testing And Evaluation (Class II - Special Controls, product code IKK).

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on July 13, 1992, 34 days after receiving the submission on June 9, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number	K922772 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 1992
Decision Date	July 13, 1992
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement