(101 days)
No
The device description and performance studies focus on standard mobility scooter components and safety testing, with no mention of AI or ML technologies.
No.
The device's intended use is to provide mobility. While it assists disabled or elderly individuals, it does not treat or cure a disease or condition. It is a mobility aid, not a therapeutic device.
No
The device is described as a motor-driven scooter used for mobility, not for diagnosis of any condition.
No
The device description clearly outlines numerous hardware components including a frame, motor, batteries, braking system, and controls. The performance studies also focus on testing the physical characteristics and safety of the scooter, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- LANDLEX S400X Scooter Function: The description clearly states the intended use is to provide mobility to disabled or elderly persons. It is a transportation vehicle.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples or providing diagnostic information.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The LANDLEX S400X scooter is intended for an indoor/outdoor scooter that provides transportation for 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.
Product codes
89INI
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).
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:
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.
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.
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).
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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.
3
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
5
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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