Cleared Traditional

K833195 - UMBRELLA WALKER
(FDA 510(k) Clearance)

K833195 · Convaid Products, Inc. · Physical Medicine
Oct 1983
Decision
38d
Days
Class 1
Risk

K833195 is an FDA 510(k) clearance for the UMBRELLA WALKER. This device is classified as a Walker, Mechanical (Class I — General Controls, product code ITJ).

Submitted by Convaid Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983, 38 days after receiving the submission on September 19, 1983.

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

Submission Details

510(k) Number K833195 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1983
Decision Date October 27, 1983
Days to Decision 38 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