GEL-T CUSHION

• K Number: K960189
• Device Name: GEL-T CUSHION
• Manufacturer: SPAN-AMERICA MEDICAL SYSTEMS, INC.
• Date Cleared: 1996-02-07 ( 22 days)
• Product Code: KIC
• Regulation Number: 890.3175

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

§ 890.3175 Flotation cushion.

(a)
Identification. A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.(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 § 890.9.

Summary

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