(104 days)
Not Found
No
The device description and performance studies focus on basic mechanical and electrical components and standard safety testing, with no mention of AI or ML.
No
The device provides mobility aid and does not treat or cure a disease or condition, which is the definition of a therapeutic device.
No
The device is described as an indoor and outdoor transportation vehicle intended to provide mobility, not to diagnose a condition.
No
The device description clearly outlines a physical, motor-driven scooter with various hardware components (frame, motor, batteries, etc.). The performance studies also focus on testing the physical characteristics and safety of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The VCS S3T scooter is a mobility device designed to transport disabled or elderly individuals. It does not interact with or analyze biological specimens.
- Intended Use: The intended use clearly states "to provide mobility to disabled or elderly persons limited to a seated position." This is a functional purpose, not a diagnostic one.
- Device Description: The description details mechanical and electrical components related to transportation, not laboratory analysis.
- Performance Studies: The performance studies listed are related to the physical and electrical safety and durability of the scooter, not the accuracy of diagnostic results.
Therefore, based on the provided information, the VCS S3T scooter is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VCS S3T scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
89INI
Device Description
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).
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)
Non-Clinical testing:
VCS S3T scooter has been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- (4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement
- (5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- (6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- (7). California Bureau of Home Furnishings 116 Flammability Standards.
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
AUG 1 5 2005
( 05113 /
- 510(k) summary
510(k) Summary
VEHICLES TECHNOLOGY CO., LTD.
VCS S3T scooter
Sponsor's information: Cycling and Health Tech Industry R&D Center No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan, 40768 Contact person: Dr. Chang Wan-Lan Director of Testing Department Phone: +886-4-23501100 Facsimile: +886-4-23504590 e-mail: cwl@tbnet.org.tw Date prepared: April 22, 2005
Proprietary and Manufacturer information: VEHICLES TECHNOLOGY CO., LTD.
No. 238, San Tsun 1st , Yung Kang City, Tainan, Taiwan, 71072 Registration number: 3005037465 Contact person: Chun-Pi Shen, Manager Phone: +886-6-2436477 Facsimile: +886-6-2436479 e-mail: vcs.power@msa.hinet.net
Device
Trade name: VCS S3T scooter Common name: Electrical scooter Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II
1
Predicate devices
Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 3-Wheeled Electric Scooter, DK S320 k number: K033241 Date cleared: 11/10/2003
Intend use of device
VCS S3T scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).
Substantial equivalence:
The VCS S3T scooter is substantially equivalent to the Be-Mobile 3-Wheeled Electric Scooter, DK S320 (K033241) manufactured by TUNG DENG ENTERPRISE CO., LTD..
Analysis of comparison of design, function and feature of VCS S3T scooter to TUNG DENG DK S320 (K033241), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.
While there are minor differences in performance specifications of the scooters,
2
these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Vehicles believes that the VCS S3T scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
Non-Clinical testing
VCS S3T scooter has been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- (4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement
- (5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- (6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- (7). California Bureau of Home Furnishings 116 Flammability Standards.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Vehicles Technology Co., LTD. c/o Dr. Chang Wan-Lan Director of Testing Department Cycling and Health Tech Industry R&D Center No. 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768
Re: K051131
Trade/Device Name: VCS S3T Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 6, 2005 Received: July 11, 2005
Dear Dr. Wan-Lan:
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. Chang Wan-Lan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and if you is ought mains of substantial equivalence of your device to a legally premaince notification. "The start 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) 276-0115. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millherson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): _K051131
Device Name: VCS S3T
Indications for Use:
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Milleson
General. Restorative d Neurological Devices
(Posted November 13, 2003)