21 CFR 880.5100 — Bed, Ac-Powered Adjustable Hospital
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5100
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 70 | |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 2 | 2 | |
| OSI | Bariatric Bed | 2 | 0 |
Special Controls
FNL — Bed, Ac-Powered Adjustable Hospital
*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.
eCFR
LLI — Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
*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.
eCFR
OSI — Bariatric Bed
*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.
eCFR
