(60 days)
Not Found
No
The description details a standard power scooter with manual hand controls and no mention of AI/ML terms or functionalities.
No.
The device is a power scooter providing mobility assistance, not directly treating a disease or condition.
No
The device is described as a power scooter intended to provide mobility, not to diagnose a medical condition. Its function is to assist movement for individuals restricted to a seated position.
No
The device description clearly describes a physical power scooter with a base, wheels, seat, battery, and hand controls, indicating it is a hardware device.
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 aid, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a power scooter with wheels, a seat, battery operation, and hand controls. This aligns with a mobility device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
- Performance Studies: The performance testing focuses on electrical and mechanical standards for mobility devices, not diagnostic accuracy metrics.
Therefore, the TEH LIN Power Scooter, TL-822 is a mobility device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
INI
Device Description
The TEH LIN Power Scooter, TL-822 is an indoor / outdoor Power Scooter that is four-wheeled with a seat. It has a base with a battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with 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): 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
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
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
SEP 2 4 2004
July 22, 2004
દ દ 510(k) SUMMARY "
Submitter's Name: TEH LIN Prosthetic & Orthopaedic Inc.
No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C.
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
TEH LIN Power Scooter, TL-822 Power Scooter Motorized 4-Wheeled Vehicle, Class II, 21 CFR 890.3800
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 Power Scooter, TL-822 is an indoor / outdoor Power Scooter that is It has a base with four-wheeled with a seat. battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with 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 POWERED SCOOTER TL-588 (K022698)
T11
1
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
No. 7, Wu Chuan 7th Road, WuKu Industrial Park,
Taipei County, Taiwan R.O.C.
Fax: 886-2-22991030 Telephone: 886-2-22991901 http://www.tehlin.com.tw E-mail: tlco@ms2.hinet.net
To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, maximum speed, weight limit, and two seat for the new device. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent.
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 We believe that FDA can decide the subject device and the only minor differences exist. predicate device are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three bars extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2004
Teh Lin Prosthetic & Orthopaedic, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K042012
Trade/Device Name: Teh Lin Power Scooter TL-822 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 31, 2004 Received: September 7, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the thave been reclassified in accordance with the provisions of the Federal Food, Drug, do noos that have been 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 Tod may, dicrerer, mains of the Act include requirements for annual registration, listing of general voltaren providering 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 If your de rees to such additional controls. Existing major regulations affecting your device can may or babyer to been 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 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 or uny i 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.
3
Page 2 - Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you're begin inding of substantial equivalence of your device to a legally premaired 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 If you desire specific acrios is 301) 594-4659. Also, please note the regulation entitled, Comact the Office of Compuners as (bet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational 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 A. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: TEH LIN POWER SCOOTER TL-822
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
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
L
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K042012