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K Number
K230001
Device Name
Electric Scooter (Model: M2020)
Manufacturer
Guangdong Prestige Technology Co., Ltd.
Date Cleared
2023-07-05

(183 days)

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

I is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

Electric Scooter (Model: M2020)

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for an electric scooter (Model: M2020) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses:

  • The FDA's determination of substantial equivalence for an electric scooter.
  • Regulatory requirements for the device (e.g., registration, listing, labeling, good manufacturing practices).
  • The product code (INI) and regulation number (21 CFR 890.3800), which pertain to "Motorized Three-Wheeled Vehicle."
  • Indications for Use of the electric scooter: "It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided input does not describe such a device or 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).