ELITE 3 LOW AIR LOSS BED
Device Facts
| Record ID | K945042 |
|---|---|
| Device Name | ELITE 3 LOW AIR LOSS BED |
| Applicant | Pegabus Egerton, Ltd. |
| Product Code | FNL · General Hospital |
| Decision Date | Mar 16, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5100 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
