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General Use Pneumatic Tourniquet

Page Type
Product Code
Definition
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation.
Physical State
The device is shaped and sized to fit around a patient's limb.
Technical Method
The device performs its intended use by applying targeted pneumatic pressure to the affected area on the body.
Target Area
Limb, extremity
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.5910
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5910 Pneumatic tourniquet

§ 878.5910 Pneumatic tourniquet.

(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

General Use Pneumatic Tourniquet

Page Type
Product Code
Definition
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation.
Physical State
The device is shaped and sized to fit around a patient's limb.
Technical Method
The device performs its intended use by applying targeted pneumatic pressure to the affected area on the body.
Target Area
Limb, extremity
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.5910
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5910 Pneumatic tourniquet

§ 878.5910 Pneumatic tourniquet.

(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]