21 CFR 880.6775 — Device, Patient Transfer, Powered
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6775
Identification
A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.
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 |
|---|---|---|---|---|
| FRZ | Device, Patient Transfer, Powered | 2 | 5 |
Special Controls
FRZ — Device, Patient Transfer, Powered
*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