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K Number
K050691
Device Name
R. POON MEDICAL PRODUCTS WHEELCHAIRS
Manufacturer
R. POON MEDICAL PRODUCTS CO., LTD.
Date Cleared
2005-04-21

(35 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

R. Poon Medical Products Co., Ltd. Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA to R. Poon Medical Products Co., Ltd. regarding their wheelchairs. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about:

  • Acceptance criteria for a device's performance.
  • A study proving a device meets acceptance criteria.
  • Performance metrics, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

It focuses solely on the regulatory approval process for a mechanical wheelchair, not on the technical performance evaluation of an AI/ML-based device as implied by your detailed request.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).