IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR

K030432 · Imc-Heart Way LLC · ITI · May 1, 2003 · Physical Medicine

Device Facts

• Record ID: K030432
• Device Name: IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
• Applicant: Imc-Heart Way LLC
• Product Code: ITI · Physical Medicine
• Decision Date: May 1, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.

Device Story

Electric powered wheelchair; provides mobility for adults with physical impairments. Device input: user manipulation of hand control. Transformation: electrical energy from battery powers motors to drive wheels. Output: physical movement of wheelchair. Used in home or community settings; operated by patient. Benefits: restores independent mobility for individuals unable to ambulate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric powered wheelchair; battery-powered motor system; hand-operated control interface; standard wheelchair form factor.

Indications for Use

Indicated for adults with mobility impairments who can maintain a sitting position and operate a simple hand control.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2003

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

Re: K030432

Trade Name: IMC-Heartway Model HPS Electric Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 22, 2003 Received: April 23, 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. 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:

Device Name: Model HPS Electric Powered Wheelchair

The intended use of the IMC- Heartway Model HPS Wheelchair is to Indications For Use: provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <div> <img alt="signature" src="signature.png"/> </div> <div>(Division Sign-Off)</div> </div> | |
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| | Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K 030432 | |
| Prescription Use | OR | Over-The-Counter Use <img alt="checkmark" src="checkmark.png"/> |