(29 days)
Not Found
No
The description focuses on basic mechanical and electrical components of a powered scooter and does not mention any AI/ML capabilities or related terms.
No.
The device's stated intended use is to provide mobility to persons restricted to a seated position, not to treat or cure a medical condition.
No
The device is described as a powered scooter intended for mobility, not for diagnosing medical conditions.
No
The device description clearly describes a physical, battery-operated powered scooter with a base, wheels, seat, and hand controls, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic one.
- Device Description: The description details a powered scooter for transportation, not a device used to examine specimens from the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
IVD devices are used to perform tests on specimens (like blood, urine, or tissue) to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
INI
Device Description
The TEH LIN Powered Scooter, TL-560 is an indoor / outdoor Powered Scooter that It has a base with four-wheeled with a seat. is battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.
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)
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
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).
0
KOSIII 6
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
No. 7, Wu Chuan 7th Road, WuKu Industrial Park,
MAY 3 1 2005
Taipei County, Taiwan R.O.C.
Telephone: 886-2-22991901 Fax: 886-2-22991030 E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw
510(k) SUMMARY " દ દ
Submitter's Name: TEH LIN Prosthetic & Orthopaedic Inc.
No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C.
April 25, 2005
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
TEH LIN Power Scooter, TL-560 Powered Scooter Powered Scooter, Class II, 21 CFR 890.3860
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The TEH LIN Powered Scooter, TL-560 is an indoor / outdoor Powered Scooter that It has a base with four-wheeled with a seat. is battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
Legally marketed device for substantial equivalence comparison:
TEH LIN POWER SCOOTER TL-821 (K042011)
1
TEH LIN PROSTHETIC & OF
No. 7, Wu Chuan 7th Road, WuKu Industrial Park,
Taipei County, Taiwan R.O.C.
Telephone: 886-2-22991901 Fax: 886-2-22991030
E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. The batteries used are the same brand that is certified by UL. The control systems for the two devices are same brand i.e., Penny & Giles EGIS type for the two devices. The recharge for the two devices are used the same resource, and the recharge is certified by UL. Besides, the foldable frame, the maximum speed, removable arm type, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS.
Thus the same safety level for the two devices is assured. The major differences existing of the two Power Scooters are the different overall dimension, tires, seat size, weight limit, weight capabilities, safe climbing angle, and cruising range between the two devices. Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. So the new device is substantially equivalent to the predicate devices in this aspect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.
Public Health Service
MAY 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Teh Lin Prosthetic and Orthopaedic Incorporated C/o Dr. Ke-Min Jen Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin Chu City, China (Taiwan) 300
Re: K051116
Trade/Device Name: TEH LIN Power Scooter, TL-560 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle -Regulatory Class: II Product Code: INI Dated: April 25, 2005 Received: May 2, 2005
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been mind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer of the have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been rout 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 r ou may , mere over in 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 r read o o a roude a determination that your device complies with other requirements of the Act that I Drederal 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 Of N Fart 677, huolity 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.
3
Page 2- Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) I this letter will anow you to begin maniesing your and equivalence of your device to a legally premiter notification: "The 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 If you desire specific advice for your ac (240) 276-0120 . Also, please note the regulation entitled, colliation of Compulance in (21 the Part 807.97). You may obtain Misolanding by reference to premains. Fibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: TEH LIN Power Scooter, TL-560_
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use __ V
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styet Rhodes
Sign-Off (Division Division of General, Restorative, and Neurological Devices
Page 1 _of _1
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510(k) Number_________________________________________________________________________________________________________________________________________________________________