(29 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
WU'S POWER WHEELCHAIR, MAMBO 3
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:
- A table of acceptance criteria and the reported device performance: Not available in this document.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
- 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.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in this document.
- The sample size for the training set: Not available in this document.
- 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.
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APR 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WU'S Tech. Co., LTD c/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K030707
Trade/Device Name: WU'S Power Wheelchair, MAMBO 3 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 28, 2003 Received: March 6, 2003
Dear Dr. Jen:
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 - Dr. Jen Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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 M Melkers
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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510 (K) NUMBER ( IF KNOW ): __ TBA DEVICE NAME: WU'S POWER WHEELCHAIR, MAMBO 3
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
Prescription Use _ OR Over-The-Counter - User✓_
( Per 21 CFR 801.109 ) National Format 1-2-96 )
for Mark n Milkan
(Division Sign-Off)
Restorative
K030707
) Number __
§ 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).