Cleared Traditional

K823154 - SHOWER STOOL W/HANDLES
(FDA 510(k) Clearance)

K823154 · Orthion Corp. · Physical Medicine device

Nov 1982

Decision

16d

Days

Class 1

Risk

K823154 is an FDA 510(k) clearance for the SHOWER STOOL W/HANDLES. This device is classified as a Aid, Transfer (Class I - General Controls, product code IKX).

Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 16 days after receiving the submission on October 20, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number	K823154 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 1982
Decision Date	November 05, 1982
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—