(47 days)
To provide an optional means of mobility for physically challenged people.
F-11 Folding Power Chair
The provided document is a 510(k) clearance letter from the FDA for the F-11 Folding Power Chair. This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/CADe device.
The questions you've asked are typically relevant for the regulatory review of a diagnostic or AI-powered medical device, where performance metrics like sensitivity, specificity, or AUC are evaluated against pre-defined acceptance criteria based on clinical studies.
For a physical device like a powered wheelchair, the "acceptance criteria" and "proof" would be satisfied through different types of testing and documentation, such as compliance with recognized standards (e.g., ISO, ANSI/RESNA for wheelchairs), mechanical stress tests, battery life tests, electromagnetic compatibility (EMC) tests, and documented risk management. These details are usually found in the full 510(k) submission, not in the public-facing clearance letter.
Therefore, I cannot extract the information requested from the provided text because it does not exist within the scope of this FDA clearance letter.
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SEP 2 3 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Tinsley Wheelchair and Scooter Express L.C. 4905-A San Jacinto Houston, TX 77004
Re: K032440
Trade/Device Name: F-11 Folding Power Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 28, 2003 Received: August 12, 2003
Dear Mr. Tinsley:
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. Chris Tinsley
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 N. Millman
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 known): ___________________________________________________________________________________________________________________________________________________
Device Name: F-11 Folding Power Chair
Indications for Use:
To provide an optional means of mobility for physically challenged people.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use V
Mark A. Milhurn
Division of General, Restorative and Neurological Devices
510(k) Number Ko32440
(Optional Format 1-2-96)
§ 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).