(32 days)
Not Found
No
The device description and performance studies focus on standard electric scooter functionality and safety standards, with no mention of AI or ML.
No.
The device provides mobility assistance, which is a supportive function rather than a direct therapeutic intervention for a medical condition.
No
Explanation: The device is an electric scooter intended to provide mobility, not to diagnose a medical condition.
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 clearly states the device is for "providing mobility to persons restricted to a seated position." This is a therapeutic or assistive purpose, not a diagnostic one.
- Device Description: The description details a physical mobility device (an electric scooter) and its components. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is a mobility aid, falling under a different regulatory category than IVDs.
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 SCOOTER WT-M4A 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, EN61000-3-2: 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): 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.
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
NO. 225, YUAN-PIER ST., HSIN CA TEL: 886-3-5382105 FAX: 886-3-53821 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
11 V V 221936 L
SEP 2 1 2007
66 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, 30093, CHINA (TAIWAN)
Date summary prepared:
August 6, 2007
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S 4-WHEELED NEO SCOOTER, WT-M4A SCOOTER 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-M4A 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, EN61000-3-2: 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-M4 (K023166)
1
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are fixed. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices use the same suspension of cross brace, same size of wheels, and same type of armrest, footplate, wheel lock, and same warranty. Besides, the back upholstery materials are also the same fabric and passed the resistance ignition test.
Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motors, Thus the same safety level for the two devices is assured. and recharge.
Owing to the new device WT-M4A is huger than the predicate device WT-M4 that means the weight capability of the new device is 205kgs and the predicate device is Thus the major differences exiting the two devices are the cruising range 130kgs. per charge and incline angle. This means the cruising range of the new device is 10-15 miles and the incline angle is 8 degrees, and the predicate device is 19 miles and 12 degrees for the incline angle. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices 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 three stripes forming its body and wing. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
SEP 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WU'S TECH Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Jen, Ke-Min No. 58. Fu-Chiun St. Hsin-Chu City, 30067, Taiwan, ROC
Re: K072337
Trade/Device Name: Neo Scooter WT-M4A Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 6, 2007 Received: August 20, 2007
Dear Dr. Jen, Ke-Min:
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. Jen, Ke-Min
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 (240) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
9/21/0
Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________ K
Device Name: WU'S NEO SCOOTER, WT-M4A
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C Office of Device Evaluation (ODE) (Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number
of l
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