(31 days)
Not Found
Not Found
No
The summary describes an electric 4-wheel scooter and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as an "electric 4-wheel scooter" and the intended use is to be offered to the "consuming public." This description aligns with a general use mobility aid, which can be considered a therapeutic device designed to assist individuals with mobility impairments. Furthermore, the predicate devices are K972036 Stealth, K972037 Prowler, and K972038 Intruder, which are commonly known to be mobility scooters, reinforcing its classification as a therapeutic device.
No
The Intended Use describes an "electric 4-wheel scooter" for the "consuming public," which is a mobility aid and not typically used for diagnosis. There is no information in the provided text that suggests the device performs any diagnostic function.
No
The intended use describes an "electric 4-wheel scooter," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable." This describes a mobility aid, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: While "Not Found," the intended use clearly points away from diagnostic testing.
- Mentions image processing, AI, DNN, or ML: These are often associated with advanced diagnostic techniques, and their absence further supports it not being an IVD.
- Input Imaging Modality and Anatomical Site: These are "Not Applicable," which is consistent with a mobility device.
- Intended User / Care Setting: "consuming public" and no mention of a clinical or laboratory setting.
- Performance Studies and Key Metrics: The absence of these is expected for a mobility device, but crucial for an IVD which requires validation of its diagnostic performance.
- Predicate Devices: The listed predicate devices (Stealth, Prowler, Intruder) are likely other electric scooters, not IVD devices.
In summary, the intended use, lack of diagnostic-related features, and the nature of the predicate devices all indicate that this electric 4-wheel scooter is a mobility device and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.
Product codes
INI
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
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
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 stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken Casey 'President American Dream International Corporation 213 East Luzerne Avenue Larksville, Pennsylvania 18704
JUL - 3 1097
Re : K972036 Stealth K972037 Prowler K972038 Intruder Requlatory Class: II Product Code: INI Dated: June 2, 1997 Received: June 2, 1997
Dear Mr. Casey:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General ene oood landshould ing Fract 820) and that, through periodic - - -GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your
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Page 2 - Mr. Ken Casey
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.
This letter will allow you to begin marketing your devices as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (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 devices, 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 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,
Mark N Milbern
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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X972038 510(k) Number (if known):
Device Name: ADI 4-Whool Scooter
Indication For Use:
To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter Use_
(Optional Format l-2-96)