ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)

K063320 · Imc-Heart Way LLC · ITI · Feb 27, 2007 · Physical Medicine

Device Facts

• Record ID: K063320
• Device Name: ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
• Applicant: Imc-Heart Way LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.

Device Story

Electric powered lift wheelchair (Model Vision P13) provides mobility and vertical elevation. Input: user operation via standard joystick hand control. Output: powered forward/reverse movement and vertical lift. Used by patients with mobility impairments to improve accessibility to surroundings. Operated by the patient. Benefits include increased independence and environmental access.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powered wheelchair with electric motor, joystick control interface, and vertical lift mechanism. Class II device (21 CFR 890.3860).

Indications for Use

Indicated for individuals weighing up to 350 lbs with the physical and cognitive capacity to operate a standard joystick hand control, requiring powered mobility and vertical lift functionality for accessibility.

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

IMC-Heartway, LLC % Mr. Michael Chen President 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912

1-EB 27 2007

Re: K063320

Trade/Device Name: Electric Powered Lift Wheelchair, Model Vision (P13) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 19, 2007 Received: February 21, 2007

Dear Mr. Chen:

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. Michael Chen

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Mélkerson 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

510K number: K063320

Device Name: Model - Vision (P13) Lift Wheelchair

Indications For Use: The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
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AND/OR

| Over-The-Counter Use (21 CFR 801 Subpart C) | |
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(PLEASE DO NOT WRITE BELOW, THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Gene and Neurologica

| 510(k) Number | 4063320 |
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