Cleared Traditional

WALK & ROLL

K841700 · Maddak, Inc. · Physical Medicine
May 1984
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K841700 is an FDA 510(k) clearance for the WALK & ROLL, a Chair, With Casters (Class I — General Controls, product code INM), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984, 18 days after receiving the submission on April 23, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K841700 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1984
Decision Date May 11, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code INM — Chair, With Casters
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100