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K Number
K031272
Device Name
C.T.M. MOBILITY SCOOTER, MODEL HS-120
Manufacturer
C.T.M. HOMECARE PRODUCT, INC.
Date Cleared
2003-05-20

(28 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
K012791
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Description

The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text describes a 510(k) submission for a mobility scooter and does not contain information about acceptance criteria or a study proving its performance in the context of medical device AI or diagnostic tools. The document is for a physical device (a mobility scooter) and explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, I cannot generate the requested table and study details.

The document focuses on:

  • Device Identification: C.T.M. Mobility Scooter HS-120.
  • Substantial Equivalence: Comparison to a legally marketed predicate device (C.T.M. Mobility Scooter HS-320).
  • Device Description and Intended Use: An indoor/outdoor electric scooter for disabled or elderly persons.
  • Testing Conducted: Mention of tests listed in a "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995." However, specific results or acceptance criteria for these tests are not detailed in the provided text.
  • Lack of Performance/Clinical Data: Crucially, it states that comparative performance testing and clinical evaluations were not submitted.

To answer your request, I would need a document that describes the acceptance criteria for a specific performance metric (e.g., sensitivity, specificity, accuracy for a diagnostic device) and details a study designed to demonstrate that the device meets those criteria.

§ 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).