HOVEROUND MPV-5 POWERCHAIR

K042545 · Hoveround Corp. · ITI · Oct 21, 2004 · Physical Medicine

Device Facts

• Record ID: K042545
• Device Name: HOVEROUND MPV-5 POWERCHAIR
• Applicant: Hoveround Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 21, 2004
• 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

The Hoveround MPV-5 Powerchair is a powered wheelchair designed to provide mobility for individuals restricted to a seated position. It functions as a motorized transport device, allowing users to navigate their environment independently. The device is intended for use by patients with mobility impairments; it is operated by the user via a control interface. The powerchair assists in daily mobility, potentially improving patient quality of life and independence. It is designed for use in various settings, including homes and community environments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device classification and intended use.

Technological Characteristics

Powered wheelchair (21 CFR 890.3860, Product Code ITI). Electrically powered mobility device.

Indications for Use

Indicated for individuals with mobility limitations who are restricted to a seated position.

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

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

OCT 2 1 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: K042545

Trade/Device Name: Hoveround MPV-5 Powerchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: October 5, 2004 Received: October 6, 2004

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 for associous 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) This icher wif anow you to ough finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific acrited for Joan acon 2011-01-0120. Also, please note the regulation entitled, Connact the Ories of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mioritiation on 500 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,

Nadi A. Wilkerson

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 MPV-5 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N-Millken

Division of General, Restorative, and Neurological Devices

(k) Number K042545

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510(k) Number