(30 days)
Not Found
No
The description focuses on the mechanical and electrical components of an electric scooter and does not mention any AI or ML capabilities.
No
The device is described as an electric scooter for mobility, not for treating a disease or condition. While it aids people with restricted mobility, which can be a result of a medical condition, the scooter itself provides assistance rather than therapy.
No
The device description indicates it is an electric scooter for mobility, and the intended use specifies it provides mobility to persons restricted to a seated position. There is no mention of it being used for diagnosis, disease detection, or monitoring physiological states.
No
The device description clearly states it is an "indoor / outdoor electric scooter" with physical components like wheels, a seat, armrests, and a basket, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide 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 details a physical mobility device (an electric scooter) with components like wheels, a seat, and controls. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in the body.
- Diagnosing diseases or conditions based on sample analysis.
- Using reagents or assays.
The device is clearly a mobility aid, not a diagnostic tool.
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
The WU'S SCOOTER WT-T3H is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
Performance Testing: EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WU'S SCOOTER WT-T3D (K032488)
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
WUS TECH CO., LTD. K091212
NO. 225. YUA TEL: 886-3-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
2 7 2009 MAY
510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY; 30093, CHINA (TAIWAN)
Date summary prepared:
Device Name:
April 17, 2009
Proprietary Name: WU'S 3-WHEELED ELECTRICAL SCOOTER, WT-T3H Common or Usual Name: SCOOTER Classification Name: MOTORIZED 3-WHEELED VEHICLE, Class II,
21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The WU'S SCOOTER WT-T3H is an indoor / outdoor electric scooter that is battery.
anavated on Indo operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
WU'S SCOOTER WT-T3D (K032488)
1
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CH FAX: 886-5-5382191 TEL: 886-5-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
The intended uses, weight limit 250 lbs, maximum speed 4 mph, safety climbing angle 8°, back upholstery, and warranty period between the new device WT-T3H and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The new device is more simple and easy to use, thus the major difference existing for new device is the overall dimension, the size of tires, weight, and the cruising range are differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.
Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. `We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design.
Public Health Service
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WU's Tech Co., Ltd. % ROC Chinese-European Industrial Research Soc. Dr. Ke-Min Jen No. 58. Fu-Chiun Street Hsin-Chu City 30067 China (Taiwan)
Re: K091212
Trade/Device Name: WU'S ELECTRICAL SCOOTER, WT-T3H Regulation Number: 21 CFR 890.3800 Regulation Names: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 17, 2009 Received: April 27, 2009
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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) 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 controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lead be advised a determination that your device complies with other requirements of the Act that I Dr has intable and regulations administered by other Federal agencies. You must or any I outhar state are are requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical of it far overy, accemig (21 CFR 803); good manufacturing practice requirements as set de receited daverse overies (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Ke-Min Jen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K 09/2/2 510(k) Number:
Device Name: WU'S ELECTRICAL SCOOTER, WT-T3H
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091212
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