(25 days)
The intended use is to provide mobility to persons limited to a seated position.
Not Found
The provided text is a 510(k) premarket notification approval letter for the Hoveround E100 Powerchair. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance metrics for the device itself.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on the regulatory approval process and states the intended use of the powerchair, but does not include technical specifications, performance evaluation data, or ground truth details.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Mr. Tony DiGiovanni Director of Engineering Hoveround Corporation 2151 Whitfield Industrial Way Sarasota, Florida 34243
Re: K043069
Trade/Device Name: Hoveround E100 Powerchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 16, 2004 Received: November 8, 2004
Dear Mr. DiGiovanni:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and nave determined the arrased predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted in vice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Fodgral Food. Drug commerce prior to May 28, 1970, the encenture with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Unit devices that have been reclassince in accordance was rear over in interest of (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval single of the and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, basjon to the one of registration, listing of
general controls provisions of the Act include requirements for annual registration, list general controls provisions of the rict networks some in the manage inst 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 classified (sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlls. Extruments of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal 11.5 concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a studential complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must or any Federal Statutes and regulations adminding, but not limited to: registration and listing (2 l comply with an the Act 3 requirements, mercessed in any and ice requirements as set CFK Part 807), labeling (21 CFR Part 800); and If applicable, the clectronic fordly in the quality systems (Sections 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 5 10(k) I his letter will anow you to begin maileting your antial equivalence of your device to a legally premits that notification. The PDA mailing of basification 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), prease if you desire specific advice for your do need on our car as a most the regulation entitled, and contact the Office of Complance at (210) = 16 = 21 = 16 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 0 = 0 = 1 = 1 = = 5 = = = $ ( = = = $ ( = = = $ ( = = = $ ( = = = $ ( = = = $ ( = = " Misoranding by relevence to premarker nouthead.in and the Act from the Division of Small other general Information on your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, International and Something://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliken
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):
Device Name: Hoveround E100 Powerchair
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K043069 |
| Page 1 of |
§ 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).