AMIGO MODEL 590000

• K Number: K983987
• Device Name: AMIGO MODEL 590000
• Manufacturer: AMIGO MOBILITY INTL., INC.
• Date Cleared: 1999-06-08 ( 211 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.

Device Description

AMIGO MODEL 590000 (Joystick)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device (Amigo Model 590000, a joystick-controlled personal transportation device for walking-impaired individuals). It is not a study report or clinical trial document. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or any details about a study proving the device meets acceptance criteria for an AI/ML product.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to existing predicate devices, not on a new study demonstrating performance against specific acceptance criteria in the way you've outlined for an AI/ML product.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 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).