LLI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5100
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 2019: 95 · 2020: 16 · 2023: 20 · 2024: 20 · 2025: 26 · 2026: 1,579
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 |
|---|---|---|
| CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC (K022387) | Craftmatic Organization, Inc. | 2002-09-19 |
| CRAFTMATIC ELECTRIC ADJUSTABLE BED (K840787) | Contour, Inc. | 1984-06-13 |
Track LLI automatically
Every clearance here is in the API, with alerts when new ones post.