(27 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is for a simple mobility scooter.
No
The device is described as an electric scooter for mobility, and its purpose is to provide transportation, not to treat or diagnose a medical condition.
No
The device is described as an electric scooter for mobility, and its intended use is to provide mobility to individuals, not to diagnose any condition.
No
The device description clearly identifies the product as an "Electric Scooter," which is a physical hardware device, not software.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Travel Ease Electric Scooter, Pioneer 5 is a mobility device designed to help individuals with limited mobility move around. It does not involve the analysis of biological specimens.
- Intended Use: The intended use clearly states it's for providing mobility to adults, not for diagnostic testing.
Therefore, based on the provided information, the Travel Ease Electric Scooter, Pioneer 5 is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Travel Ease Electric Scooter, Pioneer 5 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
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
adult persons
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2001
Winston Anderson Vice President Merits Health Products Company, LTD. P.O. Box 150356 Cape Coral, Florida 33915
Re: K013788
Trade Name: Travel Ease Electric Scooter, Pioneer 5 Regulation Number: 890.3800 Regulation Name: Motorized Three Wheel Vehicle Regulatory Class: II Product Code: INI Dated: November 1, 2001 Received: November 14, 2001
Dear Mr. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your booted esternined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to muleations for use success in the energent medical Device Amendments, or to devices that have May 20, 1970, the chaonsance 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 therefore, marker the do received to equirements for annual registration, listing of devices, Controls provisions or the ice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been as a success Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand interest announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toure of actived 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 or any I 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 forth in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Winston Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you're ough finding of substantial equivalence of your device to a legally premaired 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 IT you desire specific acrise for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fut 0091. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1897 - 1859 - 155 - 15 - 15 - 4639. Also, please note the your do roo, pitude while by reference to premarket notification" (21CFR Part 807.97). I general information on your responsibilities under the Act may be obtained from the Outcr general intonnation on one of the mational 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 yours,
Susan Walker, MS
Celia M. Witten, Ph.D., M.D. 0 لس Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1013788/A'
of Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if Known): K013788
Device Name: Travel Ease Electric Scooter, Pioneer 5
Indications for Use:
The intended use of Travel Ease Electric Scooter, Pioneer 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
leRida
Winston Anderson Vice President Merits Health Products, Inc.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescripton Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional format 1-2-96)
Susan Walker m
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013788
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