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K Number
K023581
Device Name
COMFORT AGILE SCOOTER, LY-EW303
Manufacturer
COMFORT ORTHOPEDIC CO. LTD.
Date Cleared
2002-12-02

(39 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
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 seated position.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle (Comfort Agile Scooter, LY-EW303). It confirms that the device is substantially equivalent to legally marketed predicate devices.

The text does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details on sample sizes, data provenance, or study design.
  3. Information about experts, ground truth establishment, or adjudication methods.
  4. Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information.

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).