PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER

K031897 · Imc-Heart Way LLC · INI · Sep 23, 2003 · Physical Medicine

Device Facts

• Record ID: K031897
• Device Name: PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
• Applicant: Imc-Heart Way LLC
• Product Code: INI · Physical Medicine
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

The intended use of the PF-2 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Device Story

Model PF-2 is a four-wheel electric scooter designed to provide mobility for adults. The device is operated by the user via simple hand controls. It functions as a motorized vehicle to assist individuals with limited mobility in navigating their environment. The device is intended for use by patients who can independently sit on the scooter and manipulate the controls. It serves as a personal mobility aid, enhancing patient independence.

Clinical Evidence

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

Technological Characteristics

Four-wheel electric scooter; motorized vehicle; hand-controlled operation; class II device (21 CFR 890.3800).

Indications for Use

Indicated for adults requiring mobility assistance who possess the physical capacity to sit on the scooter and operate simple hand controls.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Submission Summary (Full Text)

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SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Mr. Juan Carlos Rivera President IMC-Heartway, LLC 6140 Mid Metro Drive, Suite 6 Fort Myers, FL 33912

Re: K031897

Trade/Device Name: Model PF-2, Four Wheel Electric Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 23, 2003 Received: August 27, 2003

Dear Mr. Rivera:

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. Juan Carlos Rivera

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 M. Millan, Ph.D., M.D.

elia 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 Statement

510K number:

Device Name: Model PF-2, Four Wheel Electric Scooter

The intended use of the PF-2 is to provide mobility to adults with the Indications For Use: ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number OR Over-The-Counter Use_ Prescription Use______________________________________________________________________________________________________________________________________________________________