MP-3 POWER BASE CHAIR

K982066 · Merits Health Products., Inc. · ITI · Aug 31, 1998 · Physical Medicine

Device Facts

• Record ID: K982066
• Device Name: MP-3 POWER BASE CHAIR
• Applicant: Merits Health Products., Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

Device Story

MP-3 Power Base Chair is a motorized wheelchair designed for individuals with mobility impairments and limited upper body strength. Device provides powered mobility as an alternative to manual wheelchairs. Operated by the user via integrated controls; intended for daily use to facilitate independent movement. Benefits include restored mobility and reduced physical exertion for users unable to self-propel.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity to predicate.

Technological Characteristics

Power base wheelchair; motorized propulsion system; intended for indoor/outdoor mobility. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for handicapped individuals unable to ambulate, specifically those with insufficient upper body strength to propel a manual 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.

Predicate Devices

• Jazzy power base wheelchair (Pride Healthcare, Inc.)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

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

K982066 Re : Trade Name: MP-3 Power Base Chair Requlatory Class: II Product Code: ITI Dated: June 8, 1998 Received: June 11, 1998

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 Regulations, Title 21, Parts 800 to 895. ਸੇ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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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" (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,

Ph.D., M.D. Celia M. Witten/ Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K982066 |
|---------------------------|-----------------------|
| Device Name: | MP-3 Power Base Chair |

Indications For Use:

The Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

It is similar in design to the Jazzy power base wheelchair manufactured by Pride Healthcare, Inc.

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## Conci rrence of CDRH, Office of Device Evaluation (ODE)

bcoollefs
(Division Sign-Off

ne a Resourante Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

: 上一篇: 上一篇:

OR

Over-The-Counter Use X

(Optional Formal 1-2-96)

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