TEH LIN POWERED WHEELCHAIR, MDG-601

K041752 · Teh Lin Prosthetic & Orthopaedic, Inc. · ITI · Aug 5, 2004 · Physical Medicine

Device Facts

• Record ID: K041752
• Device Name: TEH LIN POWERED WHEELCHAIR, MDG-601
• Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Battery-operated indoor/outdoor powered wheelchair; four-wheeled base with seat. Rider-operated via hand controls on steering column. Disassemblable for transport; includes onboard battery charger. Used by patients with mobility restrictions to navigate environments. Provides independent mobility; improves quality of life for users.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, and IEC61000-3-3: 1995 for electromagnetic compatibility and performance requirements.

Technological Characteristics

Battery-powered wheelchair; four-wheeled base; hand-controlled steering column. Disassemblable design. Complies with ANSI/RESNA WC/Vol.2-1998 and IEC/EN standards for electrical safety and EMC.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance.

Regulatory Classification

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.

Predicate Devices

• TEH LIN POWERED WHEELCHAIR MDG-201 (K022696)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail] 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:

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.

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

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: [phone] Fax: [phone] E-mail: [e-mail] 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 [phone]. 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 [phone] or [phone] 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 ।