MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33

K020002 · Transworld Mobility Distribution, LLC · INI · Mar 21, 2002 · Physical Medicine

Device Facts

• Record ID: K020002
• Device Name: MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
• Applicant: Transworld Mobility Distribution, LLC
• Product Code: INI · Physical Medicine
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a stable sitting position on the scooter and have the capacity to operate a simple hand control.

Device Story

P-33 is a battery-operated, three-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 mobility limitations in navigating their environment. The device is intended for personal use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated, three-wheel electric scooter. Motorized vehicle classification (21 CFR 890.3800).

Indications for Use

Indicated for adults requiring mobility assistance who can maintain a stable seated position 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 2 1 2002

Transworld Mobility Distribution, LLC Mr. Juan C. Rivera President 6140 Mid Metro Drive, Suite 6 Fort Meyers, Florida 33912

Re: K020002

K020002
Trade Name: P-33, Battery Operated, Three-Wheel Electric Scooter Regulation Number: 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: December 30, 2001 Received: January 2, 2002

Dear Mr. Rivera:

We have reviewed your Section 510(k) premarket notification of intent to market the device we liave reviewed your bootion of re(i) prohibed is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to indications for use stated in the choosal Device Amendments, or to device that have May 26, 1970, the chaculent dato of the Federal Food, Drug, and Cosmetic Act been reclassified in accordance will all proval application (PMA). You may, (Act) that do not require approval of a presenters controls provisions of the Act. The general therefore, market the device, subject to and generals for annual registration, listing of devices, controls provisions of the Act mender requirentibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (soc above) ans. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major research and lik be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I outsts concerning 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 studios of a basevice complies with other requirements of the Act that I DA has made a decornmissions administered by other Federal agencies. You must of ally rederal statutes and regulations and and limited to: registration and listing (21 comply with an the Act 3 requirements, normaliacturing practice requirements as set CI K I at 607), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Juan Rivera

This letter will allow you to begin marketing your device as described in your Section 510(k) I has letter will and w yourse FDA finding of substantial equivalence of your device to a legally premated predicated 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 Compinates al (ass 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 O inision 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 W. Milliken

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 Statement

510K number: 《ΟΖΟΟΟ Ζ

Device Name: Model P-33, Three Wheel Electric Scooter

The intended use of the P-33 is to provide mobility to adults with the Indications For Use: Indications I or Ose. - - The micility 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)

Mark A. Wilkerson

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

510(k) Number KOZOOO Z

Prescription Use_

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________