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K Number
K022699
Device Name
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
Manufacturer
FOREVER YOUNG ENT. CO., LTD.
Date Cleared
2002-09-13

(31 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

TRANSFER COMPANION HR3000 MANUAL WHEELCHAIR

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a manual wheelchair. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

Therefore, I cannot provide the requested information based on the given input.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).