HOVEROUND SE-3 POWERCHAIR

K042920 · Hoveround Corp. · ITI · Dec 3, 2004 · Physical Medicine

Device Facts

• Record ID: K042920
• Device Name: HOVEROUND SE-3 POWERCHAIR
• Applicant: Hoveround Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Hoveround SE-3 Powerchair is a powered wheelchair designed to provide mobility to individuals who are limited to a seated position. It functions as a motorized transport device, allowing users to navigate their environment. The device is intended for use by patients with mobility impairments. It is operated by the user to facilitate independent movement. The device benefits the patient by restoring or enhancing personal mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble a person with outstretched arms.

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: K042920

Ro42920
Trade/Device Name: Hoveround SE-3 Powerchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: October 21, 2004 Received: October 22, 2004

Dear Mr. DiGiovanni:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is substantised in interstate referenced above and nave ecelimined the actrise to bedicate devices marketed in interstate for use stated in the enclosure) to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment day its the Federal Food. Drue, commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while in the proval application (PMA).
and Cosmetic Act (Act) that do not require approval astroly sources of the Act . The and Cosmetic Act (Act) that do not require approval or the general controls provisions of the Act. The You may, therefore, market the device, subject to tire general registration, listing of
general controls provisions of the Act include required it' its asseinst misbranding a general controls provisions of the Act mender requirements of the management 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 (see above) more in the startering your device can
may be subject to such additional controls. Title of to 900 to 808 - In addition FDA may may be subject to such additional controlis. Existing may or 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peachartergening 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 FDA s issialice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decidination that your acceral agencies. You must ation and ligit or any Federal Statutes and regulations administered of othinited to: registration and listing (21 l comply with and the Act 3 requirements, mercains, and manufacturing practice requirements as setting destrong CFR Part 807); labening (21 CFR Part 807); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicabl forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket nothcation: "The PDF miaing of easification 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 advice for Jour at 10-10-20120. Also, please note the regulation entitled, p Colliact the Office of Compunes and (21 transmit (21CFR Part 807.97). You may obtain Missuranuing of Icrerchee to premail.orgibilities under the Act from the Division of Small other general information on your responsion.com at its toll-free number [phone] or Manufacturers, International and Ooness http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark N Melleman

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): K

Hoveround SE-3 Powerchair Device Name:

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)

Mark M. Millerson

Division of General. Restorative, and Neurological Devices

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