OLYMPUS MOBILE CHAIR/COUCH

• K Number: K962528
• Device Name: OLYMPUS MOBILE CHAIR/COUCH
• Manufacturer: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
• Date Cleared: 1996-12-12 ( 168 days)
• Product Code: FZK
• Regulation Number: 878.4950

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

§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.

(a)
Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.(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 § 878.9.

Summary

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