FDA product code ILM: Bath, Sitz, Powered
ILM is the FDA product code for bath, sitz, powered. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under ILM, from 2 different applicants. The average 510(k) review took 130 days (median 130).
Classification
| Field | Value |
|---|---|
| Device name | Bath, Sitz, Powered |
| 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 ILM clearance
Top ILM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keith Products, Inc. | 1 | 1996-04-01 |
| Wall Manufacturer, Inc. | 1 | 1982-12-07 |
Most recent ILM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953796 | Keith Products, Inc. | BANKS HYDRO-THERAPY CHAIR | 1996-04-01 | 231 |
| K823327 | Wall Manufacturer, Inc. | PORTABLE SHOWER BATH | 1982-12-07 | 29 |
Recalls for ILM devices
openFDA lists no recalls for product code ILM.
Frequently asked questions
What is FDA product code ILM?
ILM is the FDA product code for bath, sitz, powered. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel.
What device class is ILM?
Class II, regulation 21 CFR 890.5100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILM?
Across 2 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most ILM clearances?
Keith Products, Inc. (1); Wall Manufacturer, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ILM
- Run a recall and safety report across every ILM manufacturer
- Watch product code ILM 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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