(29 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The TEH LIN Powered Scooter, TL-360 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. 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.
The provided text is a 510(k) Pre-Market Notification for a powered scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document, as it describes a comparison to a predicate device and not a standalone performance study with specific acceptance criteria and ground truth establishment.
Here's what can be inferred or stated as not available based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail criteria for specific performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-821 (K042011)). | The summary for substantial equivalence comparison states:Intended Use: Same as predicate.Batteries: Same brand (UL certified) as predicate.Control Systems: Same brand (Penny & Giles EGIS type) as predicate.Recharge: Same resource (UL certified) as predicate.Other Shared Features: Foldable frame, maximum speed, safe climbing angle, removable arm type, same warranty on component and frame, and back upholstery material (passed resistance ignition test by SGS) are the same as predicate.Major Differences: Different overall dimension, tires, seat size, weight limit, weight capabilities, and cruising range. |
Study Details
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Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" of data in the context of AI or diagnostic devices. It's a comparison of physical product specifications and certifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant in this type of submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device, but not an AI/diagnostic device that would involve human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the established safety and performance characteristics of the predicate device, demonstrated through adherence to standards (EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). The new device is deemed substantially equivalent based on matching key technical specifications and certifications.
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The sample size for the training set: Not applicable. This document does not describe an AI/ML algorithm or a "training set."
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How the ground truth for the training set was established: Not applicable.
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MAY 3 1 2005
1051118
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
46 510(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.
April 26, 2005
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
TEH LIN Power Scooter, TL-360 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 rests to a seated position.
Description of the device:
The TEH LIN Powered Scooter, TL-360 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)
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5051118
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
のところです。 このため、 このため、 この
2/2
No. 7, Wu Chuan 7th Road, WuKu Industrial Park,
Tainci 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 batteries used are the The intended use between the two devices is the same. 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, the safe climbing angle, 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, 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.
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: K051118
Trade/Device Name: TEH LIN Power Scooter, TL-360 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 26, 2005 Received: May 2, 2005
Dear Mr. Jen:
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 - Dr. Ke-Min Jen
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 yours,
Stupt Rlwdn
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
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Indications for Use
K051118 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: TEH LIN Power Scooter, TL-360
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)
rence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page_ 1__of __ 1
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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).