Cleared Traditional

K926053 - ELD-ARONDAK CHAIR
(FDA 510(k) Clearance)

K926053 · Alert Care, Inc. · Physical Medicine device

Mar 1993

Decision

111d

Days

Class 1

Risk

K926053 is an FDA 510(k) clearance for the ELD-ARONDAK CHAIR. This device is classified as a Chair, With Casters (Class I - General Controls, product code INM).

Submitted by Alert Care, Inc. (Borden, US). The FDA issued a Cleared decision on March 22, 1993, 111 days after receiving the submission on December 1, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number	K926053 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 01, 1992
Decision Date	March 22, 1993
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement