Product code LLI— General Hospital
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
- Classification name
- Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Device class
- Class 2
- Regulation
- 21 CFR 880.5100
- Advisory panel
- General Hospital
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LLI
FDA has cleared devices under product code LLI between 1984 and 2002, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 1984
Top applicants under product code LLI
Adverse events under product code LLI
product code LLI- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LLI
Data sourced from openFDA. This site is unofficial and independent of the FDA.