(28 days)
KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ20 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.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA approval letter for a medical device called the "KYMCO ForU EQ20 scooter."
The document focuses on:
- Device identification: Trade name, common name, classification, and intended use.
- Predicate devices: Listing two other scooters (AVANTICARE SA4022 and LERADO CHINA LIMITED ForU EQ30) as substantially equivalent.
- Substantial equivalence claim: Stating that minor performance differences do not alter the intended function, use, or safety/effectiveness.
- FDA approval: The letter confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the given text. This document is a regulatory approval, not a scientific study report.
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OCT 2 8 2008
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KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: +886-7-3822526 FAX: +886-7-3825834
510(k) Summary
Device
Trade name: KYMCO ForU EQ20 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
Predicate devices
AVANTICARE SA4022 (K051538), LERADO CHINA LIMITED ForU EQ30 (K072630), KWANG YANG MOTOR CO. LTD.
Intend use of device
KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The KYMCO ForU EQ20 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 KYMCO ForU EQ20 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) and ForU EQ30 (K072630) manufactured by LERADO CHINA LIMITED and KWANG YANG MOTOR CO. LTD., respectively.
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, KWANG YANG MOTOR CO., LTD. believes that the KYMCO ForU EQ20 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kwang Yang Motor Co. Limited % Ms. Junnata Chang 14F-2 NO. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220
OCT 2 8 2008
K082901 Trade/Device Name: KYMCO ForU EQ20 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 18, 2008 Received: September 30, 2008
Dear Ms. Chang:
Re:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Junnata Chang
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 M Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known):
Device Name: KYMCO ForU EQ20
Indications for Use: To provide mobility to disabled or elderly persons limited to a seated position.
Over-The-Counter Use __X Prescription Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) (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
Q.D. Der Dr.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number | K082901
(Posted November 13, 2003)
§ 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).