(60 days)
Not Found
Not Found
No
The summary describes a mobility scooter and contains no mention of AI, ML, or related technologies.
No
The device is described as an electric scooter for mobility, not for treating or diagnosing a medical condition.
No
Explanation: The device is an electric scooter intended for mobility, not for diagnosing medical conditions.
No
The device is described as an "Electric Scooter," which is a physical hardware device for mobility, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adults. It is a physical mobility aid.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, diagnostic testing, or any other activity related to in vitro examination.
Therefore, based on the provided information, the Travel Ease Electric Scooter, Pioneer 2 is a mobility device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
Product codes
INI
Device Description
Travel Ease Electric Scooter, Pioneer 2
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
adult
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Anderson Vice President MERITS Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K011707
Trade/Device Name: Travel Ease Electric Scooter, Pioneer 2 Regulation Number: 890.3800 Regulatory Class: II Product Code: INI Dated: July 25, 2001 Received: July 25, 2001
Dear Mr. Anderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stired in the energently to regionent date of the Medical Device Amendments, or to devices that price to rial) 20, 20, 2011, 11:45 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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.
1
Page 2 - Mr. Winston Anderson
This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntification. 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 11 you active 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the promotion and advertising of your device, (2017) 594-1639. I rush of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mmmhhmma
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
Page_of_of____________________________________________________________________________________________________________________________________________________________________
Comments of the comments of 510(k) Number (if known):
Travel Ease Electric Scooter, Pioneer 2 Device Name:_
Indications For Use:
The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
leRda
Winston Anderson Vice President Merits Health Products, Inc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MAMuhleUDO for ann
(Division Sign-Coff) (Division of General, Restorative and Neurological Devices
510(k) Number K071707
OR Over-The-Counter UseX
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)