(62 days)
The intended use is to provide mobility to persons limited to a seated position.
Not Found
This document does not contain the information requested for acceptance criteria and the study details.
The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair (Hoveround Power Wheelchair, model HD700). It states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.
However, this letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Information on MRMC studies or standalone algorithm performance, as it's a physical medical device, not an AI/software device.
The letter primarily focuses on the regulatory clearance for the device based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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SEP 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony DiGiovanni Director of Engineering Hoveround Corporation 2151 Whitfield Industrial Way Sarasota, Florida 34243
Re: K042033
Trade/Device Name: Hoveround Power Wheelchair, model – HD700 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 10, 2004 Received: September 13, 2004
Dear Mr. DiGiovanni:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 tise stated in the encrosure) to regars the Medical Device Amendments, or to commerce pror to may 20, 1977, is accordance with the provisions of the Federal Food, Drug, de necs that have occh receire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is olassinou tontrols. Existing major regulations affecting your device can thay or babyet to back as a suese as 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 r lease ve actived that I Drisons that your device complies with other requirements of the Act that I Dr Hab Intatutes and regulations administered by other Federal agencies. You must or any I cathar bather 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 CI K Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic rolar in all also gains of the Actions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Tony DiGiovanni
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier will anow you to organ finding of substantial equivalence of your device to a legally premaired predicated. " 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 acriously 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 other general micronal 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. Milken
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
510k number (if known): K042033
Device Name: Hoveround Power Wheelchair, model- HD700
The intended use is to provide mobility to persons limited Indications For Use: to a seated position.
Prescription Use (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K04 2033
510(k) 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).