MP3CF ELECTRIC WHEELCHAIR

K012802 · Merits Health Products., Inc. · ITI · Sep 18, 2001 · Physical Medicine

Device Facts

• Record ID: K012802
• Device Name: MP3CF ELECTRIC WHEELCHAIR
• Applicant: Merits Health Products., Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.

Device Story

The MP3CF is a powered wheelchair designed to provide mobility to adults with limited physical mobility. The device is operated by the user via simple controls, allowing the patient to navigate independently. It is intended for use by individuals who maintain the cognitive and physical capability to manage wheelchair operation. By providing a motorized sitting platform, the device assists users in daily mobility, potentially increasing independence and quality of life. It is intended for use in various environments where a wheelchair is appropriate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair; Class II device; Product Code ITI; Regulation 890.3860. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for adults with limited mobility who are capable of operating simple controls and controlling a power wheelchair while in a sitting position.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2001

Mr. Winston Anderson Vice President Merits Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915

Re: K012802

Trade/Device Name: MP3CF Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: August 10, 2001 Received: August 21, 2001

Dear Ms. Anderson:

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. Winston Anderson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to be finding of substantial equivalence of your device to a legally prematicated predicated with 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 11 you dealer specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0671. Additionally, for questions on the promotion and advertising of Compinative at [phone] of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Nil Rt. Oglene for

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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Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ mp3C Device Name:_

Indications For Use:

The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.

Signature

Winston Anderson Vice President Merits Health Products, Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nris for inca

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

**510(k) Number** K012802

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

SK.32