MP-3C POWER BASE CHAIR, MODEL MP3C

K011687 · Merits Health Products., Inc. · ITI · Aug 3, 2001 · Physical Medicine

Device Facts

• Record ID: K011687
• Device Name: MP-3C POWER BASE CHAIR, MODEL MP3C
• Applicant: Merits Health Products., Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.

Device Story

MP3C Power Base Chair; motorized wheelchair for adult mobility. Device operated by user via simple controls; provides independent navigation. Intended for individuals with mobility impairments capable of operating a power wheelchair. No complex data processing or software-driven clinical decision support; mechanical mobility device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power-driven wheelchair (Class II, Product Code ITI). Operates via electric motor and battery power. Standard wheelchair form factor with user-operated control interface.

Indications for Use

Indicated for adults requiring mobility assistance who possess the cognitive and physical capability to operate simple power wheelchair controls.

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 - 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K011687

Trade/Device Name: MP3C Power Base Chair, Model MP3C Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: July 25, 2001 Received: July 25, 2001

Dear Mr. Anderson:

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 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). 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. Winston Anderson

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 Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

MMMMMMMMMM for can

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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510(k) Number (if known): K011687

MP3C Device Name:_

Indications For Use:

The intended use of the MP3C is to provide mobility to adults, 1 lie michded use of the his bave the capability to operate a few ninked to a situing posses.
simple controls and the ability to control a power wheelchair.

Winston Anderson

Vice President Merits Health Products

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K011687
OR Over-The-Counter Use √

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)