JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II

K031342 · Jason Marine Enterprises, Inc. · ITI · Jul 10, 2003 · Physical Medicine

Device Facts

• Record ID: K031342
• Device Name: JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
• Applicant: Jason Marine Enterprises, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Model Seeker II, is to provide mobility to adults in rough terrain, with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.

Device Story

Model Seeker II is an electric power wheelchair designed for adult mobility in rough terrain. Device operates via simple hand control interface, allowing user to navigate and position themselves. Intended for use by individuals with sufficient physical capacity to transfer into a sitting position and operate manual controls. Provides patient mobility and independence in outdoor or uneven environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric power wheelchair; hand control interface; designed for rough terrain mobility. Class II device (21 CFR 890.3860).

Indications for Use

Indicated for adults requiring mobility assistance in rough terrain who possess the physical capacity to transfer into a sitting position and operate a hand control.

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

JUL 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Gagnon President Jason Marine Enterprises, Inc. 4311 NW 64" Avenue Coral Springs, FL 33067

Re: K031342

Trade/Device Name: Model Seeker II, Electric Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 27, 2003 Received: July 1, 2003

Dear Mr. Gagnon:

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. Brian Gagnon

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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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## Indications for Use Statement

K031342 510K number:

Device Name: Model Seeker II, Electric Power Wheel Chair

The intended use of the Model Seeker II, is to provide mobility to adults Indications For Use: in rough terrain, with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K031342

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use