ALTERNATING PRESSURE AIR FLOTATION MATTRESS

• K Number: K972153
• Device Name: ALTERNATING PRESSURE AIR FLOTATION MATTRESS
• Manufacturer: DECUBITI CONCEPTS, INC.
• Date Cleared: 1997-07-31 ( 52 days)
• Product Code: FNM
• Regulation Number: 880.5550

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

§ 880.5550 Alternating pressure air flotation mattress.

(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Summary

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