CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025

• K Number: K010644
• Device Name: CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
• Manufacturer: SKIL-CARE CORP.
• Date Cleared: 2001-05-18 ( 74 days)
• Product Code: FMQ
• Regulation Number: 880.6760

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

§ 880.6760 Protective restraint.

(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(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.

Summary

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