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K Number
K031314
Device Name
TMC ELECTRICAL SCOOTER, EASY 411
Manufacturer
TMC TECHNOLOGY CORP.
Date Cleared
2003-09-04

(133 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

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Description

TMC Electrical Scooter, Easy 411

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a "TMC Electrical Scooter, Easy 411". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

  • Confirming the substantial equivalence of the device to a predicate device.
  • Outlining regulatory requirements for marketing the device.
  • Stating the intended use of the device.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance and the methods used to evaluate it.

§ 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).