(52 days)
Not Found
No
The description details a standard electric mobility scooter with manual controls and no mention of AI/ML terms or functionalities.
Yes.
The device's intended use is to "provide mobility to persons restricted to a seated position," which describes a therapeutic purpose.
No
The device description and intended use indicate it is an electric scooter for mobility, not for diagnosing medical conditions. The performance studies also relate to electrical and safety standards for mobility devices, not diagnostic accuracy.
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 taken from the 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 biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
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-M3A 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)
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits. The digits appear to be '1682963'. The numbers are written in a cursive style, with some connections between the digits. The image has a simple, clean background, allowing the digits to be easily visible.
TEL: 886-3-5382105 FAX : 886-3-538 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
NOV 2 4 2008
September 28, 2008
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:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S 4-WHEELED NEO SCOOTER, WT-M3A 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-M3A is an indoor / outdoor electric scooter that is battery It has a base with three-wheeled, a seat, two armrests, and a front basket. operated. 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-M4A (K072337)
1
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHI FAX: 886-3-538219 TEL: 886-3-5382105 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
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 two devices have the same weight limit, maximum speed, incline angle, korb climbing ability, groove crossing, use the same suspension of cross brace, same size of wheels, 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, and Thus the same safety level for the two devices is assured. recharge.
Owing to the predicate device WT-M4A is four wheels and huger than the subject device WT-M3A is three wheels and so light that means the totally weight of the predicate device is 100kgs and the new device is 91kgs. Besides, the major differences exiting the two devices are the cruising range per charge and turn radius. The cruising range of the new device is 1020 miles and the turn radius is 37.8", the predicate device is 1015 miles for the cruising range and 53.1" for the turn radius. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wu's Tech Company, Limited % ROC Chinese-European Industrial Research Soc. Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, 30067 China (Taiwan)
NOV 2 4 2008
Re: K082963
Trade/Device Name: Wu's Neo Scooter, WT-M3A Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 28, 2008 Received: October 03, 2008
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
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Page 2 - Dr. Ke-Min Jen
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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K 510 (K) Number ( If Known ): __
Device Name: WU'S NEO SCOOTER, WT-M3A
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 General, Restorative, and Newrological Devices
510(k) Number
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