(58 days)
Not Found
Not Found
No
The summary describes a basic electric scooter for mobility and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is an electric scooter designed for mobility, not for treating or diagnosing medical conditions.
No
Explanation: The device, an electric scooter, is intended for mobility and does not mention any function for diagnosing diseases or medical conditions.
No
The device description clearly identifies it 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Travel Ease Electric Scooter, Pioneer 4 is a mobility device designed to help adults with limited mobility move around. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for providing mobility, not for diagnostic purposes.
Therefore, based on the provided information, the Travel Ease Electric Scooter, Pioneer 4 is not an IVD.
N/A
Intended Use / Indications for Use
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Product codes
INI
Device Description
Travel Ease Electric Scooter, Pioneer 4
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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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: K011753
Trade/Device Name: Travel Ease Electric Scooter, Pioneer 4 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 devident of a we nave reviewed your Section 9 rotty neversantially equivalent (for the indications for use above and we nave determined the actreced predicate devices marketed in interstate commerce Stated in the enclosure) to logally manove of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may, dicrerers, lannovisions of the Act include requirements for annual provisions of the Act. "The general controls process 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 (Fremarket Approval), it may of sale of Federal Regulations, Title 21, Parts 800 to 895. arreculty equivalent determination assumes compliance with the Current Good A substantially equirements, 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 mispections, the rood and Drag result in regulatory action. In addition, FDA may publish comply with the GMT Togalazer and our 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Driving of castion 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 desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in viao alaguestions on the promotion and advertising of your device, (301) 594-4639. 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 miormation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Amuleeson on
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
K011753
Page 1 of 1
ROOM STATE 510(k) Number (if known);
Travel Ease Electric Scooter, Pioneer 4 Device Name:
Indications For Use:
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
elbert C. Cole
William Anderson
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)
osmithelity so career (Division Sign-Off) Division of General, Restorative
and Neurological Devices
Kollars 510(k) Number -Over-The-Counter Use V Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)