Cleared Traditional

K941569 - CAREMOR CLINER
(FDA 510(k) Clearance)

Apr 1994
Decision
26d
Days
Class 1
Risk

K941569 is an FDA 510(k) clearance for the CAREMOR CLINER. This device is classified as a Chair, With Casters (Class I - General Controls, product code INM).

Submitted by Winco, Inc. (Ocala, US). The FDA issued a Cleared decision on April 26, 1994, 26 days after receiving the submission on March 31, 1994.

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

Submission Details

510(k) Number K941569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date April 26, 1994
Days to Decision 26 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INM — Chair, With Casters
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3100