EXPRESSAIRE TORUNIQUET SYSTEM

• K Number: K955552
• Device Name: EXPRESSAIRE TORUNIQUET SYSTEM
• Manufacturer: SMITH & NEPHEW RICHARDS, INC.
• Date Cleared: 1996-01-05 ( 31 days)
• Product Code: KCY
• Regulation Number: 878.5910

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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