FDA product code ILJ: Bath, Hydro-Massage
ILJ is the FDA product code for bath, hydro-massage. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel. FDA has cleared 73 510(k) submissions under ILJ, from 50 different applicants. The average 510(k) review took 125 days (median 38). FDA has posted 10 recalls for ILJ devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bath, Hydro-Massage |
| Device class | Class II |
| Regulation | 21 CFR 890.5100 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ILJ clearance
Top ILJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dazey Products Co. | 6 | 1977-11-02 |
| Arjo-Century, Inc. | 4 | 1995-08-28 |
| Setma, Inc. | 4 | 1986-01-03 |
| Penner Manufacturing, Inc. | 3 | 2004-04-05 |
| Century Manufacturing Co. | 3 | 1990-09-18 |
45 more applicants have ILJ clearances. See the full list in Caduvo.
Most recent ILJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110994 | Arjohuntleigh, Inc. | PARKER 500 | 2011-07-06 | 89 |
| K082951 | Arjo Hospital Equipment AB | IMMERSION HYDROBATH | 2009-04-08 | 187 |
| K052479 | Enneking Medical, Inc. | MBATH 1000 (60) | 2006-01-26 | 139 |
| K040772 | Penner Manufacturing, Inc. | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | 2004-04-05 | 10 |
| K012061 | Penner Manufacturing, Inc. | SUPERIOR BATH, MODEL 6300 | 2001-07-19 | 17 |
Recalls for ILJ devices
10 product recalls in 1 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-08-13.
| Year | Recalls |
|---|---|
| 2025 | 10 |
Frequently asked questions
What is FDA product code ILJ?
ILJ is the FDA product code for bath, hydro-massage. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel.
What device class is ILJ?
Class II, regulation 21 CFR 890.5100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILJ?
Across 73 cleared submissions the average was 125 days from receipt to decision (median 38).
Which companies have the most ILJ clearances?
Dazey Products Co. (6); Arjo-Century, Inc. (4); Setma, Inc. (4); Penner Manufacturing, Inc. (3); Century Manufacturing Co. (3).
Have ILJ devices been recalled?
Yes: 10 product recalls across 1 recall events; the most recent began 2025-08-13.
Next steps
- Run an FDA pathway report with predicate devices for product code ILJ
- Run a recall and safety report across every ILJ manufacturer
- Watch product code ILJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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