(23 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard electric scooter and does not mention any AI or ML capabilities.
No
The device is a mobility aid designed to provide transportation for individuals with restricted mobility, which is not considered a therapeutic function.
No
Explanation: The device description states its purpose is to provide mobility. There is no mention of it being used for diagnosis or detection of any medical conditions.
No
The device description clearly outlines a physical, battery-operated electric scooter with hardware components like wheels, a seat, armrests, and hand controls. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "medical purposes to provide mobility to persons restricted to a seated position." This describes a device used on a person for physical assistance, not a device used to examine specimens outside the body (in vitro).
- Device Description: The description details a physical mobility aid (an electric scooter) with components like wheels, a seat, armrests, and controls. This is consistent with a mobility device, not an IVD.
- 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 samples
- Providing diagnostic information based on sample analysis
The information provided strongly indicates that this device is a mobility aid, which falls under a different category of medical devices 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 3-WHEELED NEO SCOOTER WT-T3E is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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)
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 3-WHEELED NEO SCOOTER WT-T3D (K032488)
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
WUS TECH CO.,LTD. K062790
NO. 225, YUAN-PIER ST., HSIN C TEL: 886-3-5382105 FAX . 886-3-5382 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
510(k) SUMMARY "
OCT 1 1 2006
Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)
દ્ધ
Date summary prepared:
September 12, 2006
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S 3-WHEELED NEO SCOOTER WT-T3E Electrical Scooter 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 3-WHEELED NEO SCOOTER WT-T3E is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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 3-WHEELED NEO SCOOTER WT-T3D (K032488)
1
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-5382105 FAX: 886-3-5382191 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
Summary for substantial equivalence comparison:
The intended uses, weight limit, cruising range, maximum speed, back upholstery, safety climbing angle, and warranty period between the new device WT-T3E 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 major difference existing for new device is the-overall dimension, the size of tires, and the weight 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.
2
NO. 225. YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWA TEL: 886-5-5382105 FAX: 886-5-53821 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, cruising range, maximum speed, back upholstery, safety climbing angle, and warranty period between the new device WT-T3E 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 major difference existing for new device is the overall dimension, the size of tires, and the weight 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.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that create the shape of the bird's head, body, and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT I 1 2006
Wu's Tech Co., Ltd. % Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 225, Yuan-Pier Street, Hsin Chu City, China (Taiwan)
Re: K062790
Trade/Device Name: WU's 3-Wheeled Neo Scooter, WT-T3E Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 12, 2006 Received: September 18, 2006
Dear Dr. 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.
4
Page 2 – Dr. Jen Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin makemily of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalias and thu premarket nouffication. The I DA miding of backands of 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 If you desire specific advice for your ac not an early of a can and the regulation entitled, Contact the Office of Comphance at (216) 276 Part 807.97). You may obtain "Misoranding by reletence to premarket noutheansh (= ) = = = = other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its him becamers/spancer/inde Manufacturers, International and Consulter Prosition of Consulters of Carbindustry/support/index.html.
Sincerely yours,
Karbow Budny
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510 (K) Number ( If Known ):___ K
Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-T3E
Indications for Use:
Comments of the states
the complex of the contribution of the
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
Barbara buchin
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062790
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