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Bed, Hydraulic, Adjustable Hospital

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.5110
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.5110 Hydraulic adjustable hospital bed

§ 880.5110 Hydraulic adjustable hospital bed.

(a) Identification. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

Bed, Hydraulic, Adjustable Hospital

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.5110
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.5110 Hydraulic adjustable hospital bed

§ 880.5110 Hydraulic adjustable hospital bed.

(a) Identification. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]