(173 days)
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Not Found
No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities that typically rely on these technologies. The device is described as a "Powered Wheelchair," which is a standard medical device without inherent AI/ML capabilities based on this description.
No.
The device is a powered wheelchair intended for mobility assistance, which typically falls under durable medical equipment rather than a therapeutic device that actively treats a disease or condition.
No
The device is described as an "Electro-LiteEM® Powered Wheelchair" and its intended use is for "non-ambulatory or mobility impaired individual," which clearly indicates it is a mobility aid, not a diagnostic device. There is no mention of it being used to diagnose conditions or process any medical data.
No
The device description explicitly states "Electro-LiteEM® Powered Wheelchair," which is 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 for "non-ambulatory or mobility impaired individuals," which describes a physical condition and a need for mobility assistance.
- Device Description: The device is described as a "Powered Wheelchair." This is a medical device used for mobility, not for testing biological samples.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. A powered wheelchair does not fit this description.
N/A
Intended Use / Indications for Use
For the non-ambulatory or mobility impaired individual.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body. The eagle's wings are represented by curved lines that also form the faces of the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ron Higginbotham Quality Assurance Damaco 5105 Maureen Lane Moorpark, California 93021
AUG - 5 1997
Re : K970575 Electro-LiteElite Powered Wheelchair II Requlatory Class: Product Code: ITI Dated: June 13, 1997 Received: June 16, 1997
Dear Mr. Higginbotham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ron Higginbotham
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K970575
Device Name: Electro-LiteEM® Powered Wheelchair
Indications For Use:
For the non-ambulatory or mobility impaired individual.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONLANQTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devic 510(k) Number .
Prescription Use .Per 21 CFR 801.109) OR
Over-The Counter Use