ITJClass I

Walker, Mechanical

21 CFR 890.3825 / Physical Medicine

ITJ is the FDA product code for Walker, Mechanical, a class I device type, regulated under 21 CFR 890.3825. As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 1983-11-29, and 27 recalls.

Classification record

Product code: ITJ
Device name: Walker, Mechanical
Regulation: 21 CFR 890.3825
Device class: Class I
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 14
Ingested recalls: 27

Clearances, product code ITJ

By decision year

14 clearances under product code ITJ with a decision year between 1977 and 1983, 1977 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code ITJ by decision year
Year	Clearances
1977	4
1979	2
1981	1
1982	3
1983	4

Applicants with the most clearances

Product code ITJ

Applicants holding the most 510(k) clearances under product code ITJ
Applicant	Clearances
Maddak, Inc.	2
Convaid Products LLC	1
Fred Sammons, Inc.	1
Guardian Products Co., Inc.	1
Kaye Products, Inc.	1
Kdk Medical Products	1
Lic-Orthion	1
Manuco Manufacturing Co., Inc.	1
Meta-Morris	1
Orthion Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 334 companies shown, in name order