ILM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bath, Sitz, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5100
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 1994: 1 · 2013: 47 · 2014: 61 · 2015: 14 · 2016: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BANKS HYDRO-THERAPY CHAIR (K953796) | Keith Products, Inc. | 1996-04-01 |
| PORTABLE SHOWER BATH (K823327) | Wall Manufacturer, Inc. | 1982-12-07 |
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