MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR

K061116 · Mobilife, LLC · ITI · Jul 3, 2006 · Physical Medicine

Device Facts

• Record ID: K061116
• Device Name: MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
• Applicant: Mobilife, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch occupant that wrighs up to 215 designed for an adult pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard

Device Story

MobiLife Mobil Raizer 22 is a powered personal mobility electric wheelchair; features an electrically elevating seat (up to 22 inches) to assist user reach; operated by patient via standard joystick controller; intended for adult use to provide transport mobility; device supports occupants up to 215 lbs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair; electric seat elevation mechanism (22-inch lift); joystick control interface; intended for adult use; weight capacity 215 lbs.

Indications for Use

Indicated for adult patients weighing up to 215 lbs requiring powered personal mobility. Patient must be capable of operating a standard joystick controller.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

MobiLife, LLC. c/o Mr. Steven DuFresne President 78 Enterprise Road, Unit D Delafield, Wisconsin 53018

Re: K061116

Trade/Device Name: MobiLife - Model (Mobil Raizer 22) - Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 23, 2006 Received: June 23, 2006

Dear Mr. DuFresne:

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 reclass:tied 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 mav. 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

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Page 2 - Mr. Steven DuFresne

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. 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/industry/support/index.html.

Sincerely yours,

Barbara Preem

Mark N. Melkerson 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

510(k) Number (if known): K061116 Mobilife - Model ( Mobil Raizer 22) -Device Name: Wheel chuir Vower Indications For Use: The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch occupant that wrighs up to 215 designed for an adult pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Us . (21 CFR 807 Subpart C

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bartare Buehm

Division Sign-Of Division of General, Restorative, and Ncurological Devices

**510(k) Number** K061116

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