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K Number
K972038
Device Name
INTRUDER
Manufacturer
THE BUZZZ CORP.
Date Cleared
1997-07-03

(31 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
K972037
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in the prompt. The text is a letter from the FDA to American Dream International Corporation regarding the 510(k) clearance of their "Stealth," "Prowler," and "Intruder" devices, which are described as a 4-wheel electric scooter.

The letter discusses regulatory classifications and general controls, but it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.

§ 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).