LLI · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
General Hospital · 21 CFR 880.5100 · Class 2
Overview
| Product Code | LLI |
|---|---|
| Device Name | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
| Regulation | 21 CFR 880.5100 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022387 | CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC | Craftmatic Organization, Inc. | Sep 19, 2002 | SESE |
| K840787 | CRAFTMATIC ELECTRIC ADJUSTABLE BED | Contour, Inc. | Jun 13, 1984 | SESE |
Top Applicants
- Contour, Inc. — 1 clearance
- Craftmatic Organization, Inc. — 1 clearance
