IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7

K052008 · Imc-Heart Way LLC · ITI · Sep 16, 2005 · Physical Medicine

Device Facts

• Record ID: K052008
• Device Name: IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
• Applicant: Imc-Heart Way LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 16, 2005
• 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-7 provide mobility to adults limited to thing position that have the હ to operates a simple han Capa

Device Story

Model HP-7 Power Wheelchair; provides mobility for adults with limited physical mobility. Device operates via simple hand controls; allows user to navigate indoor/outdoor environments. Intended for use by patients with sufficient cognitive and physical ability to safely operate the controls. Benefits include increased independence and mobility for individuals unable to walk or use manual wheelchairs.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Powered wheelchair; hand-controlled interface; Class II device (21 CFR 890.3860); product code ITI.

Indications for Use

Indicated for adults with limited mobility who possess the physical and cognitive capacity to operate a simple hand-controlled power wheelchair.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2005

Mr. John Frymark President IMC-Heartway, LLC 6140 Mid Metro Drive, Suite # 6 Fort Myers, Florida 33912

Re: K052008 Trade/Device Name: Model HP-7 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 31, 2005 Received: September 7, 2005

Dear Mr. Frymark:

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 for use stated in the encream.")76, the enactment date of the Medical Device Amendments, or 10 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). and Oosmetie Fror ( roy the the device, subject to the general controls provisions of the Act. The r va meyy atches 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 he 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. John Frymark

This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket 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 n you a sen 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 N. Melkerson Acting 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

510(k) Number (if known): HP-7 Power Wheelchair Device Name: Model Indications For Use: The intended use of the HP-7 provide mobility to adults limited to thing position that have the હ to operates a simple han Capa

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AND/OF.

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

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510(k) Number_505 2008