';


Title 21 Part 880 → Subpart G → §880.6785

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6785

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6785

e-CFR data is current as of August 20, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6785


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6785   Manual patient transfer device.

(a) Identification. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]