HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR

K090108 · Hoveround Corp. · ITI · Mar 19, 2009 · Physical Medicine

Device Facts

• Record ID: K090108
• Device Name: HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
• Applicant: Hoveround Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The intended use is to provide mobility to persons limited to a seated position.

Device Story

Hoveround Teknique FWD mk4 is a front-wheel drive power wheelchair; provides mobility for individuals with limited ability to walk; operated by user via joystick controller; device transforms electrical energy from batteries into mechanical motion via motors; intended for indoor/outdoor use; assists users in daily activities by providing independent navigation; benefits include increased mobility and independence for patients with physical limitations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Front-wheel drive power wheelchair; electric motor powered; joystick control interface; standard power wheelchair construction materials; intended for indoor/outdoor mobility.

Indications for Use

Indicated for persons limited to a seated position requiring a power wheelchair for mobility.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hoveround Corporation % Mr. Tony DiGiovanni Director of Engineering 2151 Whitfield Industrial Way Sarasota, Florida 34243

Re: K090108

Trade Name: Hoveround Teknique FWD mk4 power wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 2, 2009 Received: March 2, 2009

Dear Mr. DiGiovanni:

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. Ilsting 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. Tony DiGiovanni

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milburn

Mark N. Melkerson 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): K090108

Device Name: Hoveround Teknique FWD mk4 power wheelchair

Indications For Use: The intended use is to provide mobility to persons limited to a seated position.

Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K090107