POWER SCOOTER, MODEL TL-688

K042010 · Teh Lin Prosthetic & Orthopaedic, Inc. · INI · Sep 1, 2004 · Physical Medicine

Device Facts

• Record ID: K042010
• Device Name: POWER SCOOTER, MODEL TL-688
• Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

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

Device Story

Battery-operated four-wheeled powered scooter; intended for indoor/outdoor use. Rider operates device via hand controls on steering column. Disassembles for transport; includes onboard battery charger. Provides mobility for individuals restricted to seated position. Safety features include standardized electrical components and flame-resistant upholstery. Differences from predicate include overall dimensions, weight capacity, and maximum speed; these do not impact safety profile.

Clinical Evidence

Bench testing only. Compliance with EMC and electrical safety standards including ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995.

Technological Characteristics

Battery-powered four-wheeled scooter. Components: Penny & Giles control system, HP8204A recharger. Materials: Flame-resistant upholstery (passed SGS ignition resistance test). Connectivity: None. Sterilization: N/A. Software: None.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• TEH LIN POWER SCOOTER TL-588 (K022698)

Submission Summary (Full Text)

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