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K Number
K013788
Device Name
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
Manufacturer
MERITS HEALTH PRODUCTS CO., LTD.
Date Cleared
2001-12-11

(27 days)

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

The intended use of Travel Ease Electric Scooter, Pioneer 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.

Device Description

Travel Ease Electric Scooter, Pioneer 5

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Travel Ease Electric Scooter, Pioneer 5," confirming its substantial equivalence to previously marketed devices. It details the regulatory classification, general controls, and the process for marketing the device, but it does not include specific performance criteria or scientific study results.

§ 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).