(41 days)
Not Found
No
The description focuses on basic motor control and battery operation, with no mention of AI/ML terms or functionalities.
No
The device is a transportation vehicle for mobility, not designed to diagnose, treat, or prevent disease. Its function is to provide mobility to disabled individuals, which is a supportive role, not a therapeutic one.
No
The device is described as a transportation vehicle for mobility, not for diagnosis.
No
The device description clearly states it is a battery-operated scooter with a tiller handle and throttle control, indicating it is a physical hardware device, not software only.
Based on the provided information, the VCS S4T scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to disabled or severely limited persons for transportation. This is a physical function, not a diagnostic one.
- Device Description: The description details a battery-operated scooter with controls for movement. 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 VCS S4T scooter falls under the category of a mobility aid or powered wheelchair/scooter, which are medical devices but not IVDs.
N/A
Intended Use / Indications for Use
VCS S4T scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.
Product codes
89INI
Device Description
The VCS S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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)
Not Found
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
K052558
TR
Vehicles Technology Co. I
No. 238, San Tsun 1st, Yung Kang City, Tainan, Taiwan Fax: +886-6-2436479 e-mail: vcs.power@msa.hinet.net Tel: +886-6-2436477
510(k) Summary
Device
Trade name: VCS S4T scooter
Common name: Electrical scooter
907 % 7 410
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device
VCS S4T 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 S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The VCS S4T scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.
There are minor differences in performance specifications of the scooters, 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 Technology believes that the VCS S4T scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.
Public Health Service
OCT 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chang Wan Lan Cycling and Health Tech Industry R&D Center/CHC No. 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 407
Re: K052558
Trade/Device Name: VCS S4T Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 12, 2005 Received: October 18, 2005
Dear Chang 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 cnactment 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.
2
Page 2 -Chang Wan Lan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your to organ finding of substantial equivalence of your device to a legally premaired predicated 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 rr you desire specific aarnoliance 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 other Echoral 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/industry/support/index.html
Sincerely yours,
Signature
Cor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): K052558
Device Name: VCS S4T
Indications for Use:
The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.
Prescription Use __________ Over-The-Counter Use _ X (Part 21 CFR 807 Subpart C) (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
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KoSZS K
(Posted November 13, 2003)