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K Number
K091418
Device Name
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
Manufacturer
C.T.M. HOMECARE PRODUCT, INC.
Date Cleared
2009-07-06

(54 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
K030387
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Description

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery operated, has three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It is provided with an off-board battery charger.

AI/ML Overview

This document is a 510(k) premarket notification for a C.T.M. Mobility Scooter HS-628. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-driven medical device.

The document states:

  • "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
  • The device is a "C.T.M. Mobility Scooter HS-628 or Orion Electric scooter Motorized three-wheeled vehicle."
  • Its intended use is to "provide transportation for a disabled or elderly person."
  • The 510(k) notification focuses on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-890) based on similar technological characteristics (e.g., both are battery operated, have two wheels, one motor, automatic braking systems).
  • It mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Wheelchairs and Scooters, and Motorized Three Wheeled Vehicles" were conducted, but the specific results or acceptance criteria are not detailed, nor are they framed as performance metrics for an AI system.

Therefore, I cannot provide the requested information for an AI-driven medical device, as this document pertains to a mobility scooter and explicitly states that comparative performance testing and clinical evaluations were not submitted. The questions you've asked are relevant for AI/ML-based medical devices or diagnostics, which this product is not.

§ 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).