Cleared Traditional

BATH TUB SEAT & BATH BOARD

K823153 · Orthion Corp. · Physical Medicine
Nov 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823153 is an FDA 510(k) clearance for the BATH TUB SEAT & BATH BOARD, 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 review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K823153 FDA.gov
FDA Decision Cleared 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 —

Device Classification

Product Code IKX — Aid, Transfer
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050