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K Number
K031309
Device Name
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
Manufacturer
KUANN DAH INDUSTRY CO., LTD.
Date Cleared
2003-07-31

(98 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

KUANN DAH, COOL TANK Motorized Scooter, KS-4L320

AI/ML Overview

I'm sorry, but this document is a 510(k) clearance letter from the FDA for a motorized scooter. It details the regulatory approval process for the device, including its classification and indications for use.

However, it does not contain any information about:

  • Acceptance criteria or reported device performance metrics in the context of a study.
  • Sample sizes for test sets or their data provenance.
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • Sample size for a training set.
  • How ground truth for a training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is purely administrative regulatory correspondence.

§ 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).