(35 days)
R. Poon Medical Products Co., Ltd. Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
Not Found
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes entwined around it.
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R. Poon Medical Products Co., Ltd. C/o Mr. Richard Graver Tech-Med Services, Inc. 10 Newton Place Hauppauge, New York 11788
Re: K050691
Trade/Device Name: R. Poon Medical Products Co., Ltd. Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 6, 2005 Received: April 7, 2005
Dear Mr. Graver:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Richard Graver
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceans your and equivalence of your device to a legally premarket notification. "The PDF Intaing of basification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac not on one on one the regulation entitled, comact the Office of Comphalled at (21 transmit (21CFR Part 807.97). You may obtain "Misbranding by reference to premance notifications of the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Postswitch Cov/cdrh/industry/support/index.html.
Sincerely yours,
Hyatt Rhodes
n C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko 90691/51
INDICATIONS FOR USE
510(k) Number (if known): N/A
Device Name: R. Poon Medical Products Co., Ltd. Wheelchairs
Indications for Use:
R. Poon Medical Products Co., Ltd. Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) -----------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stypt Rlurdy
(Division Sign-Of Division of General, Restorative, and Neurological Devices
Page 1 of _ l _
510(k) Number_ KOSD691
§ 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).