LogoFDA 510(k) Search
K Number
K021910
Device Name
COMFORT DREAMRIDER SCOOTER, LY-EW402
Manufacturer
COMFORT ORTHOPEDIC CO. LTD.
Date Cleared
2002-10-11

(123 days)

Product Code
INI
Regulation Number
890.3800
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 seated position.

Device Description

Not Found

AI/ML Overview

This document is related to a 510(k) premarket notification for a motorized three-wheeled vehicle (scooter). It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for a study. This is a regulatory clearance letter, not a study report.

§ 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).