(117 days)
The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Electric Powered Lift Wheelchair, Model Vision (P13)". This document describes the device, its intended use, and the FDA's marketing approval. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.
Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and not on the technical performance data that would typically be generated for a device study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMC-Heartway, LLC % Mr. Michael Chen President 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
1-EB 27 2007
Re: K063320
Trade/Device Name: Electric Powered Lift Wheelchair, Model Vision (P13) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 19, 2007 Received: February 21, 2007
Dear Mr. Chen:
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. Michael Chen
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 (240) 276-0120 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Mélkerson 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
510K number: K063320
Device Name: Model - Vision (P13) Lift Wheelchair
Indications For Use: The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW, THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Gene and Neurologica
| 510(k) Number | 4063320 |
|---|---|
| --------------- | --------- |
§ 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).