Cleared Traditional

K821404 - LIGHT WEIGHT ALUMINUM WALKER
(FDA 510(k) Clearance)

K821404 · Manuco Manufacturing Co., Inc. · Physical Medicine
May 1982
Decision
10d
Days
Class 1
Risk

K821404 is an FDA 510(k) clearance for the LIGHT WEIGHT ALUMINUM WALKER. This device is classified as a Walker, Mechanical (Class I — General Controls, product code ITJ).

Submitted by Manuco Manufacturing Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982, 10 days after receiving the submission on May 11, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3825.

Submission Details

510(k) Number K821404 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1982
Decision Date May 21, 1982
Days to Decision 10 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ITJ — Walker, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3825