JOWClass II

Sleeve, Limb, Compressible

21 CFR 870.5800 / Cardiovascular

JOW is the FDA product code for Sleeve, Limb, Compressible, a class II device type, regulated under 21 CFR 870.5800. As of 2026-09-10, FDA records hold 352 510(k) clearances under this code, the most recent dated 2026-07-31, and 32 recalls.

Classification record

Product code: JOW
Device name: Sleeve, Limb, Compressible
Regulation: 21 CFR 870.5800
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 354
Ingested recalls: 32

Clearances, product code JOW

By decision year

354 clearances under product code JOW with a decision year between 1977 and 2026, 2002 the highest year at 25.

Show the numbers

510(k) clearances under FDA product code JOW by decision year
Year	Clearances
1977	2
1978	2
1979	1
1980	1
1981	1
1982	1
1983	1
1984	1
1986	1
1987	1
1988	2
1989	2
1990	1
1991	4
1992	5
1993	8
1994	3
1995	5
1996	13
1997	9
1998	7
1999	5
2000	6
2001	11
2002	25
2003	9
2004	5
2005	4
2006	16
2007	6
2008	4
2009	3
2010	18
2011	11
2012	13
2013	17
2014	16
2015	10
2016	9
2017	9
2018	11
2019	11
2020	14
2021	16
2022	7
2023	6
2024	8
2025	7
2026	6

Applicants with the most clearances

Product code JOW

Applicants holding the most 510(k) clearances under product code JOW
Applicant	Clearances
Bio Compression Systems, Inc.	11
MEGO AFEK AC Ltd.	11
Hygia Health Services, Inc.	9
Medical Compression Systems (Dbn), Ltd.	9
Alliance Medical Corp.	8
Compression Therapy Concepts, Inc.	8
Medtronic, Inc.	8
Devon Medical, Inc.	8
Aircast, Inc.	7
Airos Medical Inc	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order