Anesthesiology
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- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- NGUBalloon, Liver Tamponade2Product Code
- EYRTourniquet, Gastro-Urology1Product Code
- EXMTruss, Umbilical1Product Code
- EYNTray, Irrigation, Sterile2Product Code
- FBQTrocar, Gastro-Urology2Product Code
- FZGApparatus, Air Handling, Bench2Product Code
- FZHApparatus, Air Handling, Room2Product Code
- FZIApparatus, Air Handling, Enclosure2Product Code
- GAXTourniquet, Nonpneumatic1Product Code
- KCWEpilator, High Frequency, Needle-Type1Product Code
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- KCYTourniquet, Pneumatic1Product Code
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- OJSTourniquet Kit1Product Code
- OLIFat Reducing Low Level Laser2Product Code
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use2Product Code
- QGXGeneral Use Pneumatic Tourniquet1Product Code
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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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]