ILJClass II

Bath, Hydro-Massage

21 CFR 890.5100 / Physical Medicine

ILJ is the FDA product code for Bath, Hydro-Massage, a class II device type, regulated under 21 CFR 890.5100. As of 2026-09-10, FDA records hold 73 510(k) clearances under this code, the most recent dated 2011-07-06, and 10 recalls.

Classification record

Product code: ILJ
Device name: Bath, Hydro-Massage
Regulation: 21 CFR 890.5100
Device class: Class II
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 73
Ingested recalls: 10

Clearances, product code ILJ

By decision year

73 clearances under product code ILJ with a decision year between 1977 and 2011, 1977 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code ILJ by decision year
Year	Clearances
1977	7
1979	2
1980	2
1981	4
1982	1
1983	1
1984	7
1985	3
1986	2
1987	2
1988	3
1989	2
1990	2
1991	5
1992	3
1993	1
1994	6
1995	2
1997	1
1998	7
1999	1
2000	3
2001	2
2004	1
2006	1
2009	1
2011	1

Applicants with the most clearances

Product code ILJ

Applicants holding the most 510(k) clearances under product code ILJ
Applicant	Clearances
Dazey Products Co.	6
Arjo-Century, Inc.	4
Century Manufacturing Co.	3
Heddernheimer Metallwarenfabrik GmbH	3
Penner Manufacturing, Inc.	3
Setma, Inc.	3
Aquaciser, Inc.	2
Aquatherapy Systems, Inc.	2
Arjohuntleigh AB	2
Associated Mills, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code