(77 days)
LANDLEX 402x scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position
The LANDLEX 402x 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
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.
The document is a 510(k) summary for the LANDLEX 402x scooter, which is a regulatory submission to the FDA. It declares the device's "substantial equivalence" to predicate devices, meaning it claims that it is as safe and effective as existing legally marketed devices.
However, a 510(k) summary does not typically include detailed information about specific acceptance criteria or the studies that demonstrate device performance against those criteria. It focuses on demonstrating equivalence to predicate devices, often by comparing performance specifications (as mentioned in the document "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device..."), rather than providing a rigorous independent study with specific acceptance metrics.
Therefore, the requested information, such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, is not present in this document.
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K0r3303
Besteam Technology Inc.
No.16-1, Zıqıang 1st Rd., Zhonglı Cıtv. Taoyuan Hsıen, Tarwan Phone: +886-3-4345111 Fax: +886-3-4342572
510(k) Summarv
Device
JAN 2 6 2009
Trade name LANDLEX 402x 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
LANDLEX 402x scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position
Device description:
The LANDLEX 402x 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 LANDLEX 402x 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 perfaining to safety or effectiveness Therefore, Besteam Technology Inc. believes that the LANDLEX 402x scooter is substantially equivalent to legally marketed devices currently in commercial distribution
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes on its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Admınıstration 9200 Corporate Boulevard Rockville MD 20850
Besteam Technology Inc % Junnata Chang JAN 2 6 2009 14-F No 1 Lane 25 Zhuanning Rd Banqıao China (Tarwan) 220 Re K083303 Trade Name LANDLEX 402X Regulation Number 21 CFR 890 3800 Regulation Names Motorized three-wheeled vehicle Regulatory Class II Product Code INI Dated January 9, 2009 Received January 9, 2009
Dear Junnata Chang
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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
If your device is classified (see above) into etther 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
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Page 2 - 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 Brometric'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 Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Mark M. Millerson
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 LANDLEX 402x
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 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Page 1 of 1 Concurrence of CDRH, Office of Device Evaluation (ODE)
Debra
ivision Sign-Off) Division of General, Restorative and Neurological Devices of 335 03 510(k) Number
6083303
(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).