SOMA SAFE ENCLOSURE

• K Number: K963701
• Device Name: SOMA SAFE ENCLOSURE
• Manufacturer: NOVA TECHNOLOGY CORP.
• Date Cleared: 1997-01-24 ( 130 days)
• Product Code: FNL
• Regulation Number: 880.5100

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

§ 880.5100 AC-powered adjustable hospital bed.

(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(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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