Cleared Traditional

BATHTUB TRANSFER BENCH

K821010 · Guardian Products Co., Inc. · Physical Medicine
Apr 1982
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K821010 is an FDA 510(k) clearance for the BATHTUB TRANSFER BENCH, a Aid, Transfer (Class I — General Controls, product code IKX), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982, 9 days after receiving the submission on April 12, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K821010 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1982
Decision Date April 21, 1982
Days to Decision 9 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