NOMAD FROM DYNAMIS MOBILITY LTD.

K040457 · Dynamis Mobility , Ltd. · ITI · May 19, 2004 · Physical Medicine

Device Facts

• Record ID: K040457
• Device Name: NOMAD FROM DYNAMIS MOBILITY LTD.
• Applicant: Dynamis Mobility , Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

INTENDED USE OF THE NOMA'S POWERED THE WHEELCHAIR IS TO PROVIDE SAFE PERSONAL HOBILITY TO PERSONS LIMITED TO A SEATED OPERATING A WITC ARE CAPABLE OF POSITION

Device Story

Nomad Powered Wheelchair provides personal mobility for individuals with limited physical mobility. Device operates as a seated powered wheelchair; user controls movement via integrated interface. Intended for use by individuals capable of operating the controls. Benefits include restored personal mobility and independence for users with mobility impairments.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and regulatory review.

Technological Characteristics

Powered wheelchair; 21 CFR 890.3860; Product Code ITI. Class II device.

Indications for Use

Indicated for persons with limited mobility who are capable of operating a seated powered 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

Ruth Lytle Dynamis Mobility Ltd. 2765 Thamesgate Drive Mississauga ON L4T 1G5 Canada

Re: K040457

Trade/Device Name: Nomad Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 27, 2004 Received: May 6, 2004

Dear Ms. Lytle:

We have reviewed your Scction 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 concefning 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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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 vours.

sincerely yours,

Mark N Milburn

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

KD40457 510(k) Number (if known): POWERED WHEELCHAIR Device Name: NoHAD Indications For Use:

> INTENDED USE OF THE NOMA'S POWERED THE WHEELCHAIR IS TO PROVIDE SAFE PERSONAL HOBILITY TO PERSONS LIMITED TO A SEATED OPERATING A WITC ARE CAPABLE OF POSITION

POWERED WHEELLHAIR

Prescription Use (Part 21 CFR 801 Subpart D) AND/CR

Over-The-Counter Use (21 CFR 807 Subpart C)

-The-Counter Use
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)

R. Mark N. Milkerson

Division of General, Restorative, and Neurological Devices

510(k) Number

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