Cleared Traditional

BABY WALKER W/TOY CHEST

K812474 · Maddak, Inc. · Physical Medicine
Sep 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K812474 is an FDA 510(k) clearance for the BABY WALKER W/TOY CHEST, a Exerciser, Non-measuring (Class I — General Controls, product code ION), 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 890.5370.

Submission Details

510(k) Number K812474 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 ION — Exerciser, Non-measuring
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370