(112 days)
Not Found
Not Found
No
The summary describes a mobility scooter and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, a mobility scooter, is intended to provide mobility to persons restricted to a seated position, which is a supportive function rather than a therapeutic one that treats or cures a medical condition.
No
The 'Intended Use / Indications for Use' states the device provides mobility to persons restricted to a seated position, which does not involve diagnosing any medical condition.
No
The device description clearly identifies a physical product, "WU'S 3-WHEELED NEO SCOOTER, WT-T3D," 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 clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description is for a "3-WHEELED NEO SCOOTER," which is a mobility aid.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Diagnosing diseases or conditions based on laboratory tests
- Image processing, AI/ML, or imaging modalities (which are often associated with diagnostic devices, though not exclusively IVD)
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This scooter does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
INI
Device Description
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
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): 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 Department of Health & Human Services - USA. The logo features 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 its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
WU'S Tech. Co., LTD C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K032488
Trade/Device Name: WU'S 3 - Wheeled NEO Scooter, WT - T3D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vchicle Regulatory Class: II Product Code: INI Dated: October 31, 2003 Received: November 10, 2003
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren b r (s) personalially equivalent (for the indications felerenced above and nave decembined his marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American Continents. Or to connineres provise to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alla Cosmette Ace (1 tot) market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market include requirements for annual registration, listing of general controlly provision practice, 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 is etassined (600 world). Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mcan I lease of advised that I Dr. Oradon that your device complies with other requirements of the Act that I DA has made a assessmantly other Federal agencies. You must or any I ederal statutes and survey including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 6077, laboring (21 CFR Part 820); and if applicable, the clectronic form in the quality by seems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ke-Min Jen, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Mark A. Millman
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__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOWN ): TBA DEVICE NAME: WU'S 3-WHEELED NEO SCOOTER, WT-T3D
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR | Over-The Counter Use ✓ |
|---|---|---|
| ------------------ | ---- | ------------------------------------------------------------------------ |
(Per 21 CFR 801.109) (Optional Format 1-2-96)
for
(Division Signature)
Division of General Restorative
and Neurological Devices
| 510(k) Number | K032488 |
|---|---|
| --------------- | --------- |