ITHClass II

Equipment, Traction, Powered

21 CFR 890.5900 / Physical Medicine

ITH is the FDA product code for Equipment, Traction, Powered, a class II device type, regulated under 21 CFR 890.5900. As of 2026-09-10, FDA records hold 71 510(k) clearances under this code, the most recent dated 2025-07-18, and 5 recalls.

Classification record

Product code: ITH
Device name: Equipment, Traction, Powered
Regulation: 21 CFR 890.5900
Device class: Class II
Review panel: Physical Medicine
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 71
Ingested recalls: 5

Clearances, product code ITH

By decision year

71 clearances under product code ITH with a decision year between 1977 and 2025, 2000 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code ITH by decision year
Year	Clearances
1977	2
1982	1
1983	1
1984	2
1985	2
1986	4
1987	1
1988	1
1989	3
1990	2
1992	1
1993	1
1994	2
1995	2
1996	1
1998	1
1999	4
2000	6
2001	1
2002	1
2003	4
2004	2
2005	5
2006	3
2007	2
2008	4
2009	1
2010	1
2011	1
2012	1
2014	2
2015	2
2023	1
2024	1
2025	2

Applicants with the most clearances

Product code ITH

Applicants holding the most 510(k) clearances under product code ITH
Applicant	Clearances
Axiom USA., Inc.	2
Axiom Worldwide, Inc.	2
Cert Health Sciences, LLC	2
Chattanooga Group, Inc.	2
Ever Prosperous Instrument, Inc.	2
Excite Medical of Tampa Bay LLC	2
Lossing Orthopedic, Inc.	2
North American Medical Corp (Nam)	2
Pivotal Health Solutions	2
Tru-Trac	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order