HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

K011745 · Transworld Mobility Distribution, LLC · ITI · Aug 30, 2001 · Physical Medicine

Device Facts

• Record ID: K011745
• Device Name: HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
• Applicant: Transworld Mobility Distribution, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.

Device Story

Model HP-3 is a power wheelchair designed to provide mobility for adults with physical limitations requiring a seated position. The device utilizes a simple hand control interface, allowing the user to operate the wheelchair independently. It functions as a motorized mobility aid for use in various environments. The device assists patients by restoring or enhancing independent movement, thereby improving daily living capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power wheelchair; motorized mobility device; hand-controlled interface; intended for adult use; class II medical device.

Indications for Use

Indicated for adults limited to a sitting position who possess the capacity to operate a simple hand control for mobility.

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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AUG 3 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K011745

Trade/Device Name: Model HP-3 Power Wheelchair Regulation Number: 890.3825 Regulatory Class: II Product Code: ITI Dated: May 2, 2001 Received: June 5, 2001

Dear Mr. Rivera:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Juan Carlos Rivera

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device of your device to a legally marketed notification. The FDA inding of substantial equal thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for m Yillo diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions on the presses on the regulation please contact the Office or Compliance an (81) ontification's (21CFR 807.97). Other general entitled, "Misoranding by relective to premarket from the Division of Small
information on your responsibilities under the Act may be obtained from the 1800) 638, 2011 on information on your responsionnies under the recent its toll-free number [phone] or
Manufacturers International and Consumer Assistance at its toll-boardsmapp html" Manufacturers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
[phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Milbersen

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: KO11 745

Device Name: Model HP-3, Power Wheelchair

The intended use of the HP-3 is to provide mobility to adults limited to a Indications For Use: sitting position that have the capacity to operate a simple hand control.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mulberon

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

510(k) Number k011745

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________