(101 days)
The LANDLEX S400X 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 LANDLEX S400X 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 LANDLEX S400X scooter is with a 135 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, lighting system, automatic headlight sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-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 35 km (22 miles) with 34AH which maximum speed upto 9 km/hr (5.6 mph).
Here's a breakdown of the acceptance criteria and the study information for the LANDLEX S400X scooter, based on the provided 510(k) summary:
This device is not an AI/ML powered device, therefore some of the requested information (like MRMC studies, training set, etc.) does not apply.
Acceptance Criteria and Device Performance for LANDLEX S400X Scooter
The LANDLEX S400X scooter demonstrates substantial equivalence to its predicate device, the Bewell SC 20 (K043326), by meeting established performance and safety standards for wheelchairs and motorized scooters. The acceptance criteria are largely defined by compliance with a set of international and national standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Stability | ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 Determination of static stability | Tested to and complies with this standard. |
| Speed, Acceleration, Deceleration | ANSI/RESNA WC/Vol.1 section 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair | Tested to and complies with this standard. (Maximum speed up to 9 km/hr / 5.6 mph explicitly stated in device description, reinforcing compliance with relevant speed determination). |
| Structural Integrity & Durability | ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods | Tested to and complies with this standard. |
| Electromagnetic Compatibility (EMC) | ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters | Tested to and complies with this standard. |
| CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement | Tested to and complies with this standard. | |
| IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD) | Tested to and complies with this standard. | |
| IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test | Tested to and complies with this standard. | |
| Flammability | California Bureau of Home Furnishings 116 Flammability Standards | Tested to and complies with this standard. |
| Intended Use | Provide mobility to disabled or elderly persons limited to a seated position, capable of 135 kg (300 lbs) weight capacity. | Device description explicitly states intended use and weight capacity, implying performance at this capacity. Compliance with relevant standards (e.g., structural strength) supports this claim. |
| Substantial Equivalence | Demonstrated equivalence to Bewell SC 20 (K043326) in design, function, and features. | Analysis of comparison of design, function and feature of LANDLEX S400X scooter to CHC Bewell SC 20 (K043326), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of individual devices tested, but rather indicates that the LANDLEX S400X scooter "has been tested" to the listed wheelchair standards. It is implied that at least one functional unit of the commercial device was subjected to the full battery of tests for each standard.
- Data Provenance: The testing was non-clinical, meaning it was conducted in a laboratory or test facility setting to confirm compliance with engineering and safety standards. The manufacturer is Besteam Technology Inc. in Taiwan. The testing would have been conducted by or on behalf of the manufacturer, presumably in Taiwan or a recognized testing laboratory. This is a form of prospective engineering testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable to this type of device and study. The "ground truth" for the test set is defined by the technical specifications and performance limits set forth in the international and national standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, California Flammability Standards). Compliance is determined by objective measurements against these predefined thresholds, not by expert consensus on specific cases.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop evaluations where there's subjective interpretation or a need for consensus on expert opinions. For non-clinical engineering testing against established standards, the results are objectively measured and compared to the standard's criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The LANDLEX S400X is a motorized scooter, and its evaluation focuses on engineering performance and safety standards, not diagnostic accuracy or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the LANDLEX S400X is a physical motorized scooter, not an algorithm or AI system. Its "performance" is its mechanical and electrical function and its adherence to safety standards, not an algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily compliance with established engineering and safety standards. These standards define measurable performance criteria (e.g., static stability angles, maximum speed, electromagnetic emission limits, material flammability). The tests performed against these standards provide objective evidence of device performance.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (electric scooter), not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device.
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- 510(k) summary
JUL 7 - 2005
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510(k) Summary Besteam Technology Inc. LANDLEX S400X scooter
Proprietary and Manufacturer information: Besteam Technology Inc. No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan Registration number: 3005004555 Contact person: Jack Chen, QA engineer of R&D Department Phone: +886-3-4345111 Facsimile: +886-3-4342572 e-mail: jackchen@besteamgp.com.tw Date prepared: March 16, 2005
Device
Trade name: LANDLEX S400X 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
Manufacture name: Cycling and Health Tech Industry R&D Center/CHC Name: Bewell SC 20 k number: K043326 Date cleared: 01/26/2005
Intend use of device
LANDLEX S400X scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
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Device description:
The LANDLEX S400X 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 LANDLEX S400X scooter is with a 135 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, lighting system, automatic headlight sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-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 35 km (22 miles) with 34AH which maximum speed upto 9 km/hr (5.6 mph).
Substantial equivalence:
The LANDLEX S400X scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.
Analysis of comparison of design, function and feature of LANDLEX S400X scooter to CHC Bewell SC 20 (K043326), 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, 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, Besteam believes that the LANDLEX S400X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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Non-Clinical testing
LANDLEX S400X 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 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair
- (3). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (4). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- (5). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement
- (6). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- (7). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- (8). California Bureau of Home Furnishings 116 Flammability Standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IUL 7 - 2005
Mr. Chang Wan-Lan Cycling and Health Tech. Industry R & D Center Number 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768
Re: K050793
Trade/Device Name: Landlex S400X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 9, 2005 Received: June 9, 2005
Dear Mr. 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.
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Page 2- Mr. Chang Wan-Lan
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 Office of Compliance 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 Manufacturers, 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 vours.
Stupt Clurda
Mirian C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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To: Elmar Einberg
Subject: K 050793
+0021-301-594-2358
3. Device descriptive information 3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): K050793
Device Name: LANDLEX S400X
Indications for Use:
The LANDLEX S400X 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) (Part 21 CFR 807 Subpart C) 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
Stut Plurde
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K050793 510(k) Number_ (Posted November 13, 2003)
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§ 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).