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K Number
K981121
Device Name
AMIGO RT
Manufacturer
AMIGO MOBILITY INTL., INC.
Date Cleared
1998-06-30

(95 days)

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

Intended use is personal transportation for senior active and walking impaired individuals.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter from the FDA for a device named "Amigo RT." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letters do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications for the device.

Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative regarding regulatory clearance.

§ 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).