TEKNIQUE-HOVEROUND POWER WHEEL CHAIR

K021136 · Hoveround Corp. · ITI · Apr 19, 2002 · Physical Medicine

Device Facts

• Record ID: K021136
• Device Name: TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
• Applicant: Hoveround Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Teknique-Hoveround Power Wheel Chair provides mobility for individuals restricted to seated positions. Device operates as powered wheelchair; enables user-controlled navigation in indoor/outdoor environments. Intended for patient self-use; enhances independence by facilitating movement. No complex software or algorithmic processing described.

Clinical Evidence

No clinical data provided; device is a standard powered wheelchair.

Technological Characteristics

Powered wheelchair; Class II; Product Code ITI; 21 CFR 890.3860. Mechanical mobility device.

Indications for Use

Indicated for persons limited to a seated position requiring mobility assistance.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 9 2002

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

Re: K021136

Trade/Device Name: Teknique-Hoveround Power Wheel Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 2, 2002 Received: April 9, 2002

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, 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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

Celia 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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Page 20 of

510k number: K

Teknique XHD Device Name:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
(Per 21 CFR 801.109)

for Mark A Milhersen

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Over -The-Counter UseX

(Optional Format 1-2-96)

510(k) Number_