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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
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
K103817,K113355,K113357
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.