(79 days)
Not Found
No
The description details a standard electric scooter with manual controls and no mention of AI/ML terms or functionalities.
No.
A therapeutic device is typically one that treats or prevents a disease or condition. This device provides mobility support and does not have a direct therapeutic function.
No
Explanation: The device description states its purpose is to provide mobility. There is no mention of it being used to diagnose any medical condition or disease.
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.
Based on the provided information, 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 mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details an electric scooter with features for mobility and transport. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key indicators typically associated with IVDs, such as:
- Mentions image processing
- Mentions AI, DNN, or ML (while some IVDs might use these, their absence here further supports it's not an IVD)
- Input Imaging Modality
- Anatomical Site
- Indicated Patient Age Range
- Intended User / Care Setting
- Description of training/test sets and performance studies related to diagnostic accuracy.
- Key Metrics (Sensitivity, Specificity, etc.)
The performance testing mentioned (EMC Report and standards related to electrically powered wheelchairs and scooters) is relevant to the safety and functionality of a mobility device, not an IVD.
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 (comma separated list FDA assigned to the subject device)
INI
Device Description
The WU'S 4-WHEELED SCOOTER WT-L4Jr is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, 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, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): 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.
WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)
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
NOV 1 2 2003
032617 1
O. IMM
NO. 225, YUAN-PIER TEL: 886-5-5382105 Homepage: www.wustech.com.tw ustis@ms45.hinet.net
46 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) Tel: 88 Date summary prepared: August 19, 2003 Device Name: Proprietary Name: WU'S 4-Wheeled Scooter, WT-L4Jr Common or Usual Name: Electrical Scooter Classification Name: Motor Three-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 4-WHEELED SCOOTER WT-L4Jr is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, 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, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)
1
K032617 2/2
NO. 225, YUAN-PIER ST., HSIN CHU CITY, C TEL: 886-5-5382105 FAX: 886-5-5382191 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two 4-wheelled scooters are the different controller, and the new device. WT-L4Jr, is more agile and easy to storage or transportation and the predicate device. WT-L4, is for general use. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized eagle with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
WU'S Tech. Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K032617
Trade/Device Name: WU'S 4-Wheeled Scooter, WT-L4Jr Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 3, 2003 Received: October 20, 2003
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 does not mean that FDA has made 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 comply 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Ke-Min Jen
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,
Miriam C. Provost
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
4
Page 1 of of 1
510 (K) NUMBER ( IF KNOWN ): TBA DEVICE NAME: WU'S 4-WHEELED SCOOTER, WT-L4Jr
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 )
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over - The - Counter - Use J
( Per 21 CFR 801.109 )
( Optional Format 1-2-96 )
Miriam C. Provost
General, Restorative and Neurological Devices
510(k) Number K032617