The TEH LIN Powered Scooter, TL-688 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TEH LIN Power Scooter, TL-688. It focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-588) rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for AI/diagnostic devices would.

Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation process.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of quantitative acceptance criteria and performance metrics for a diagnostic or AI device, this submission relies on demonstrating similarity to a predicate device. The "acceptance criteria" here is effectively meeting the standards of the predicate and relevant industry performance tests.

Acceptance Criterion (Demonstrated by Equivalence/Testing)	Reported Device Performance (as demonstrated by similarity to predicate or testing)
Intended Use (to provide mobility to persons restricted to a seated position)	Same as predicate device (TEH LIN POWER SCOOTER TL-588).
Battery Safety/Performance	Uses the same brand and type of batteries as the predicate, certified by UL.
Control System Performance/Safety	Uses the same brand (Penny & Giles) control systems as the predicate device.
Recharger Safety/Performance	Uses the same recharger resource (HP8204A) as the predicate, certified by UL.
Structural Integrity & Material Safety (e.g., Foldable Frame, Removable Arm Type)	Foldable frame, removable arm type, same seat size, same climbing angle, same warranty on component and frame, weight limit, maximum range per charge, and back upholstery are the same material as the predicate. Back upholstery passed the resistance ignition test by SGS.
EMC (Electromagnetic Compatibility)	Tested according to: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. (Specific results are not provided in this summary, but adherence to these standards implies satisfactory performance.)
Overall Safety Level (Based on components, materials, controls, and battery system)	"Thus the same safety level for the two devices is assured" based on the shared components, materials, and control systems with the predicate device. Minor differences in overall dimension, weight capabilities, and maximum speed are deemed "not safety aspect" and do not preclude substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a 510(k) for a powered scooter where "testing" primarily involves engineering standards and comparison to a predicate, not a "test set" of patient data.
Data Provenance: The document refers to engineering and safety standards (e.g., UL certification, SGS resistance ignition test, EMC standards) and the comparison to an existing device (TEH LIN POWER SCOOTER TL-588). The manufacturing origin is Taipei County, Taiwan R.O.C. The data is prospective in the sense that the testing was performed on the TL-688 model for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a diagnostic device relying on expert interpretation of data for ground truth. "Ground truth" here is established by engineering specifications, safety standards, and performance test results.

4. Adjudication Method for the Test Set

Not applicable. (See #3)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This type of study is not relevant for the regulatory approval of a powered scooter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Ground truth is established through:
- Compliance with recognized industry performance standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for EMC).
- Certifications from recognized testing bodies (e.g., UL for batteries and recharger, SGS for material resistance ignition).
- Direct comparison to a legally marketed predicate device (TEH LIN POWER SCOOTER TL-588) regarding components, materials, and design features.

8. The Sample Size for the Training Set

Not applicable. (See #2) This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #2 and #8)

Summary

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KO42010

TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

No. 7, Wu Chuan 7th Road, WuKu Industrial Park,

SEP - 1 2004

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.

July 20, 2004

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

TEH LIN Power Scooter, TL-688 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-688 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 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-588(K022698)

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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

Summary for substantial equivalence comparison:

The intended use between the two devices is the same. The batteries used are the same brand and same type that is certified by UL. The control systems for the two devices are same brand i.e., Penny & Giles for the two devices. The recharge for the two devices are used the same resource, HP8204A, and the recharger is certified by UL. Besides, the foldable frame, removable arm type, same seat size, same climbing angle, same warranty on component and frame, weight limit, maximum range per charge, 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 weight capabilities and maximum speed between the two devices. The overall appearance and weight differences are not safety aspect. 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms, or possibly a bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 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: K042010

Trade/Device Name: Teh Lin Power Scooter, TL-688 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 20, 2004 Received: July 26, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section >10(x) premained is substantially equivalent (for the indications ferenced above and nave determines and one interest predicate devices marketed in interstate for use stated in the cherosule) to regally the enactment date of the Medical Device Ameritants, or to commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accerative while a premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosmetic Act (Act) that to not require approvine so the general controls provisions of the Act. The You may, dielefore, market the devices, soloje it our enents for annual registration, listing of general controls provisions of the 110 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 II your device is classifica (socraory into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may be subject to such additional controlise Linkslang in 1948 - In addition, FDA may be found in the Code of Pouchal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr. 3 issuation of a backed complies with other requirements of the Act that TDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regarations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 607), adoling (21 OFF Part 820), and 820); and if applicable, the electronic forth in the quality systems (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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Wilkerson

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

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Page 1 of

510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: TEH LIN POWER SCOOTER, TL-688

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)

(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 K042010

Regulation Number and Section

§ 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).