(86 days)
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
Nomad Powered Wheelchair
This is an FDA 510(k) clearance letter for a powered wheelchair (Nomad Powered Wheelchair, K040457). This type of document does not contain the information requested regarding acceptance criteria and formal study results for device performance.
FDA 510(k) clearances establish substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. They typically do not require the rigorous clinical trial data or detailed performance studies that would be submitted for a Pre-Market Approval (PMA) application or a de novo classification.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence, not detailed performance metrics and study designs as would be found in a clinical study report or a more extensive technical file.
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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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§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).