(87 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses solely on the device's function as a powered wheelchair.
No
The device provides mobility, which is an assistive function, not a therapeutic treatment for a medical condition or disease.
No
The device description states its purpose is to provide mobility to individuals, not to diagnose any medical condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a powered wheelchair, which is typically a hardware device.
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 mobility to individuals, which is a physical function, not a diagnostic test performed on biological samples.
- Device Description: While not found, the intended use clearly points to a mobility aid.
- No mention of biological samples or diagnostic testing: The description lacks any indication of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The eLexus, as described, is a powered wheelchair, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the eLexus is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes
ITI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are formed by thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
NOV - 6 2007
Mr. Will Ridgway Sales Manager Dalton Medical Corporation 1103 Venture Court Carrollton, TX 75006
Re: K021199
Trade/Device name: Primechair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 10, 2002 Received: May 17, 2002
Dear Mr. Ridgway:
This letter corrects our substantially equivalent letter of July 12, 2002.
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 (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 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.
1
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.
This letter will allow you to continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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coting and Promoting Public Health
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| 510(k) Number (if known): | K021199 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________ eLexus
Indications For Use:
The intended use of the eLexus is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
ANUAR (Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZI199 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801_109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)