HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

K011744 · Transworld Mobility Distribution, LLC · ITI · Aug 24, 2001 · Physical Medicine

Device Facts

• Record ID: K011744
• Device Name: HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
• Applicant: Transworld Mobility Distribution, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 24, 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-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.

Device Story

Model HP-5 is a power wheelchair designed for adult users with mobility limitations who can operate a hand control. Device provides motorized mobility; features a foldable frame for transport. Operated by the patient; intended for personal use. Output is physical movement of the chair based on user input via hand controller. Benefits include increased independence and mobility for individuals restricted to a sitting position.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power wheelchair; foldable frame design; hand-controlled interface; motorized propulsion. Specific material standards or software architecture details not provided.

Indications for Use

Indicated for adults limited to a sitting position who possess the capacity to operate a simple hand control for 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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Public Health Service

AUG 2 4 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: K011744

Trade/Device Name: Model HP-5, Power Wheelchair Regulation Number: 890.3825 Regulatory Class: II Product Code: ITI Dated: May 15, 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 stated in the enormers, to the enactment date of the Medical Device Amendments, or to devices that price to ria) = 3, a read, and 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

L. Mark N. Milken

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:

Device Name: Model HP-5, Power Wheelchair

The intended use of the HP-5 is to provide mobility to adults limited to a Indications For Use: sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------|
| | for (Division Sign-Off) |
| (Divisio | Division of General, Restorative |
| Divisi | and Neurological Devices |
| and Neurological Devices | |
| 510(k) Number | 510(k) Number K011744 |
| Prescription Use_ | OR Over-The-Counter Use ✓ |