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K Number
K030356
Device Name
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
Manufacturer
COMFORT ORTHOPEDIC CO. LTD.
Date Cleared
2003-05-20

(106 days)

Product Code
ITI
Regulation Number
890.3860
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 sitting position.

Device Description

COMFORT Powered Wheelchair, Traveller LY-EB103

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a "Comfort Powered Wheelchair, Traveller LY-EB103." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

The letter does not contain:

  • A table of acceptance criteria and reported device performance.
  • Details about a study conducted to demonstrate performance, including sample sizes, data provenance, ground truth establishment, or expert reviews.
  • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).