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K Number
K021371
Device Name
SUNSPEX TECHNOLOGIES MODEL SE 02
Manufacturer
SUNPEX TECHNOLOGY CO., LTD.
Date Cleared
2002-05-16

(16 days)

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

The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Device Description

Model SE 02, Three Wheel Electric Scooter

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device: "Model SE 02, Three Wheel Electric Scooter". This letter primarily discusses regulatory approval based on substantial equivalence and does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance.

Therefore, I cannot provide the requested information. The document is a regulatory approval notice, not a study report or technical specification sheet.

§ 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).