Cleared Traditional

K833869 - CHILD'S WALKER
(FDA 510(k) Clearance)

Nov 1983
Decision
21d
Days
Class 1
Risk

K833869 is an FDA 510(k) clearance for the CHILD'S WALKER. This device is classified as a Walker, Mechanical (Class I - General Controls, product code ITJ).

Submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983, 21 days after receiving the submission on November 8, 1983.

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

Submission Details

510(k) Number K833869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1983
Decision Date November 29, 1983
Days to Decision 21 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