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K Number
K984565
Device Name
TMC-EASY-302
Manufacturer
TMC MAGNETICS & MACHINERY CORP.
Date Cleared
2000-02-16

(420 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.
The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 20 miles.

Device Description

TMC-Easy-302 MOTORIZED THREE-WHEELED SCOOTER

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a motorized three-wheeled scooter. It does not contain information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information from this document.

§ 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).