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 CodeDevice NameClassDevicesAttributes
FRZDevice, Patient Transfer, Powered25

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

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