MODIFICATION TO MP-3 POWER BASE CHAIR

K993032 · Merits Health Products., Inc. · ITI · Nov 5, 1999 · Physical Medicine

Device Facts

• Record ID: K993032
• Device Name: MODIFICATION TO MP-3 POWER BASE CHAIR
• Applicant: Merits Health Products., Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

Device Story

The MP3 is a power base chair designed to assist disabled individuals, specifically those with muscular diseases, in navigating daily living activities. It functions as a mobility aid, providing powered transport for the user. The device is intended for use by the patient to improve independence. It is operated by the user via integrated controls on the chair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power base chair for mobility assistance. Class II device (Product Code: ITI).

Indications for Use

Indicated for disabled individuals, including those with muscular disease, to assist with daily living activities.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight. The birds are arranged in a vertical stack, with the largest bird at the top and the smallest bird at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 5 1999

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

Re: K993032 Modification to MP-3 Power Base Chair Trade Name: Regulatory Class: II Product Code: ITI Dated: Undated Received: August 10, 1999

## 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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlations.

{1}------------------------------------------------

## 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 labelinq 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| 510(k) Number (if known): | K993032 |
|---------------------------|---------|
| Device Name: | MP3 |

Indications For Use:

November 4, 1999

Dear Sir:

Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

Yours truly,

Win Andu

Winston Anderson, Vice President Merits Health Products

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

ﺎ ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

Concurrence of CDRH, Office of Device Evaluation (ODE).

(Division Sign-Off)
Division of General Restorative Devices K993032
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)