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Device, Transfer, Patient, Manual

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6785
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6785 Manual patient transfer device

§ 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]

Device, Transfer, Patient, Manual

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6785
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6785 Manual patient transfer device

§ 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]