Cleared Traditional

TRANSFER BENCH

K812475 · Maddak, Inc. · Physical Medicine
Sep 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K812475 is an FDA 510(k) clearance for the TRANSFER BENCH, a Aid, Transfer (Class I — General Controls, product code IKX), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 14 days after receiving the submission on August 31, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K812475 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1981
Decision Date September 14, 1981
Days to Decision 14 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