(86 days)
None
Not Found
No
The summary describes a standard powered wheelchair and does not mention any AI or ML capabilities.
No
The device is a powered wheelchair intended for personal mobility, not for treating or alleviating a medical condition.
No
The device, a "Nomad Powered Wheelchair," is intended for mobility and does not perform any diagnostic functions.
No
The device description explicitly states "Nomad Powered Wheelchair," which is a physical hardware device. The intended use also describes a "powered wheelchair," further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide personal mobility to individuals with limited mobility. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a powered wheelchair, which is a mobility aid.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. A powered wheelchair does not fit this description.
N/A
Intended Use / Indications for Use
INTENDED USE OF THE NOMAD’S POWERED THE WHEELCHAIR IS TO PROVIDE SAFE PERSONAL MOBILITY TO PERSONS LIMITED TO A SEATED OPERATING A WITCH ARE CAPABLE OF POSITION
Product codes
ITI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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.
1
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
2
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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