(39 days)
Not Found
No
The summary describes a standard mobility scooter with mechanical controls and battery operation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The primary purpose of the device is transportation and mobility for disabled or elderly persons, not to treat or cure a medical condition.
No
Explanation: The device description states its intended use is to provide mobility to disabled or elderly persons, not to diagnose a medical condition.
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 LANDLEX P100X scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a battery-operated scooter for transportation, controlled by a tiller and throttle. This aligns with a mobility aid, not a diagnostic device.
- 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 those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
Therefore, the LANDLEX P100X scooter is a mobility device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LANDLEX P100X 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 (comma separated list FDA assigned to the subject device)
INI
Device Description
The LANDLEX P100X 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 1 4 2006
Ko60042
Besteam Technology Inc.
No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan
Fax: +886-3-4342572 Phone: +886-3-4345111
510(k) Summary
Device
Trade name: LANDLEX P100X
Common (generic) name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: INI
Classification: Class II
Predicate devices
LANDLEX S300X (K050792) / Besteam Technology Inc.
Proasia L3402 (K052378) / Proasia
Intend use of device
LANDLEX P100X 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 P100X 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 P100X scooter is substantially equivalent to the LANDLEX S300X (K050792) and Proasia L3402 (K052378) manufactured by Besteam and Proasia, 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, Besteam believes that the LANDLEX P100X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2006
Mr. Jack Chen Besteam Technology Inc. No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan, 32063
Re: K060042
Trade/Device Name: LANDLEX P100X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 03, 2006 Received: January 06, 2006
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainted in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) the actering and as a concess marketed in interstate for use stated in the encrosule) to regally manator date of the Medical Device Ameral Food. Drug commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug. devices that have been reclassince in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act, 7 and Costheile Act (Act) that to hot require approvial controls provisions of the Act. The You may, merelove, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is classified (500 a0070) ins existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or events concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri 3 issualles of a complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any it cach stututes and registerients, including, but not limited to: registration and listing (21 comply with an the 11ct 811 Part 801); good manufacturing practice requirements as set CFR Part 807); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Jack Chen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogin manteans your and equivalence of your device to a legally premarket notification. The PDF mailing of casion 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 If you desire specific advice for your ac not one one one one one the regulation entitled, Colliact the Office of Complance as (27,74) = (21CFR Part 807.97). You may obtain Misolanding of Icrerchoe to premantonsibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
_ 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): _
Device Name: LANDLEX P100X
Indications for Use:
The LANDLEX P100X 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.
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) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K060047
(Posted November 13, 2003)