TEH LIN POWERED WHEELCHAIR, MDG-601 by TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.

The TEH LIN Powered Wheelchair, MDG-601 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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

This document describes the TeH LIN Powered Wheelchair, MDG-601, and its 510(k) submission for substantial equivalence to a predicate device. The information provided heavily focuses on regulatory approval and substantial equivalence, rather than detailed performance study reports with specific acceptance criteria and detailed device performance data.

Therefore, many of the requested elements for a detailed performance study description cannot be fully extracted from the provided text.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Inferred/Missing)	Reported Device Performance (Inferred/Missing)
EMC Compliance	ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995	"EMC Report" indicates compliance was tested, but specific pass/fail or measured values are not provided.
Safety and Functional Performance	Requirements from ANSI / RESNA WC/Vol.2-1998 for electrically powered wheelchairs, controllers, and chargers (e.g., stability, braking, speed, maneuverability, durability).	"Performance Testing" states these standards were applied, implying the device met the requirements. However, specific performance metrics are not given.
Intended Use	Ability to provide mobility to persons restricted to a seated position safely and effectively.	The device is intended and asserted to meet this use. No specific metrics are provided.
Substantial Equivalence	The device has the same intended use, technological aspects, and only minor dimensions and material differences exist compared to the predicate device (TEH LIN POWERED WHEELCHAIR MDG-201).	This was the primary "acceptance criterion" of the 510(k) submission and was met, leading to FDA clearance.

2. Sample size used for the test set and the data provenance:

The document describes "Performance Testing" against standards like ANSI / RESNA WC/Vol.2-1998. However, it does not specify a sample size for tested devices. Typically, such testing involves a limited number of production or pre-production units.
Data Provenance: The testing was conducted by or on behalf of TEH LIN Prosthetic & Orthopaedic Inc. in Taiwan. The data would therefore be prospective in relation to the submission, but the location of the testing is not explicitly stated beyond the company's origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this 510(k) summary. The "ground truth" for the performance testing is adherence to engineering and safety standards (e.g., ANSI / RESNA). This is determined by standardized test procedures and measurements, not by expert consensus on clinical findings.
There are no "experts" in the sense of clinical reviewers establishing a ground truth for a diagnostic algorithm.

4. Adjudication method for the test set:

Not applicable. Performance against engineering standards does not typically involve an adjudication method in the way a clinical study with human readers would. Results are objectively measured against defined criteria.

5. 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:

No, this was not done. The device is a powered wheelchair, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical product (a powered wheelchair), not an algorithm. Its performance is inherent to its design and manufacturing, not an AI algorithm operating independently.

7. The type of ground truth used:

The "ground truth" for this device's performance is compliance with established international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). These standards define objective test methods and acceptable performance limits.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that requires a "training set." It's a manufactured medical device.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for this type of device.

Summary

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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: tlc0@ms2.hinet.net http://www.tehlin.com.tw

66 510(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 Powered Wheelchair, MDG-601 Powered Wheelchair Powered Wheelchair, 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:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: TEH LIN POWERED WHEELCHAIR MDG-201(K022696)

AUG - 5 2004

June 22, 2004

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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

Based on the above the information and the analysis, we know that the subject is device and the predicate device have the same intended use the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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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 features the department's name encircling a stylized emblem. The emblem consists of a stylized eagle with three lines representing its body and wings. The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 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: K041752

Trade/Device Name: The Lin Powered Wheelchair MDG-601 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 20, 2004 Received: July 23, 2004

Dear Dr. 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 (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 N. Milken

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__________________________________________________________________________________________________________________________________________________________________________

510 (K) NUMBER ( IF KNOW ): TBA DEVICE NAME: TEH LIN POWERED WHEELCHAIR MDG-601

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Prescription Use

510(k) Number

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)

for

Mark N

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

K041757

म् ।

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).