Last synced on 23 September 2022 at 11:05 pm

Chair, Surgical, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4960
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4960 Operating tables and accessories and operating chairs and accessories

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

(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 § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000]

Chair, Surgical, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4960
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4960 Operating tables and accessories and operating chairs and accessories

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

(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 § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000]