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K Number
K030707
Device Name
WU'S POWERED WHEELCHAIR, MAMBO 3
Manufacturer
WU'S TECH CO., LTD.
Date Cleared
2003-04-04

(29 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
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 sitting position.

Device Description

WU'S POWER WHEELCHAIR, MAMBO 3

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a power wheelchair. It is not a study report and therefore does not contain any information regarding acceptance criteria or the results of a study proving a device meets these criteria.

The letter essentially states that the FDA has reviewed the submission for the "WU'S Power Wheelchair, MAMBO 3" and determined it is "substantially equivalent" to legally marketed predicate devices. This means it can be marketed, subject to general controls provisions.

To directly answer your request:

  1. A table of acceptance criteria and the reported device performance: Not available in this document.
  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in this document.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in this document. This device is a power wheelchair, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. This device is a power wheelchair.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in this document.
  8. The sample size for the training set: Not available in this document.
  9. How the ground truth for the training set was established: Not available in this document.

In summary, this document is solely an FDA clearance letter and does not provide the detailed study information you are seeking.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).