(14 days)
The FS-series Wheelchair is manually operated mechanical wheelchair, the FS-series Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position
Foshan Wheelchair is a self-propelled, folding frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
The provided 510(k) summary for the FS-Series Wheelchair (K041814) does not contain information about specific acceptance criteria or a detailed study proving the device meets certain performance metrics.
Instead, this document is a substantial equivalence determination, which means the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device (Foshan Machinery & Equipment Import & Export Co. Series Wheel Chair, K992884) in its specifications, performance, and use.
For Class I devices like manual wheelchairs, the regulatory pathway generally relies on demonstrating substantial equivalence to a predicate device that has already met regulatory requirements, rather than requiring extensive new performance studies with specific acceptance criteria. The general controls provisions of the Act apply, including good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
Therefore, the specific information requested in your prompt (e.g., acceptance criteria table, sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is not typically found in a 510(k) summary for a device like a mechanical wheelchair seeking substantial equivalence. Such details are more common for novel, higher-risk, or complex devices, especially those involving AI or diagnostic imaging where performance metrics are critical and quantified through rigorous studies.
In summary, based on the provided document, I cannot fulfill the request as the information is not present for this type of device and regulatory submission.
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| 510(K)Summary | K0418 | |
|---|---|---|
| JUL 2 0 2004 | ||
| Submitter's Name: | Foshan Dongfang Medical Equipment Manufactory (LTD.) | |
| Address: | 2 Baohua Industrial Park Ave. Guilan Rd. Nanhai District Foshan City,Guangdong Province, China ,528252 | |
| Telephone:Fax: | 86-757-629941586-757-6232649 | |
| Contact:Date Prepared: | Mr. Pang Jianxun , General Manager |
FS Wheelchair Device Name: L
- FS Wheelchair is classified under Mechanical Wheelchair, which 3. Classification: has been classified as a Class I device, in accordance to 21 code of Federal Regulations 890.3850
- Foshan Machinery & Equipment Import & Export Co. Series Wheel 4. Predicate Device: Chair (manual, not electrical)
- Device Description:
Foshan Wheelchair is a self-propelled, folding frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
- Intended Use
The intended used Foshan Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position.
- Substantial Equivalence
The Foshan Wheelchair is substantially equivalent to the listed predicate devices in its specifications, performance and use.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
JUL 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Foshan Dongfang Medical Equipment Manufactory C/o Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, Connecticut 06470
Re: K041814
Trade/Device Name: FS-Series Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: June 28, 2004 Received: July 6, 2004
Dear Mr. Borsai:
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. Tamas Borsai
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premailed predicate device results in a classification 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 at (301) 594-4659. Also, please note the regulation entitled, Colliable of Compulance in (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number (if known) : Under application
Device Name: FS-Series Wheelchair
Indications For Use:
The FS-series Wheelchair is manually operated mechanical wheelchair, the FS-series Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position
Prescription Use______________________________________________________________________________________________________________________________________________________________
AND/OR
0ver-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkersen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041814
§ 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).