COMFORT ELECTRIC SCOOTER, LY-EW408

K072712 · Comfort Orthopedic Co., Ltd. · INI · Oct 31, 2007 · Physical Medicine

Device Facts

• Record ID: K072712
• Device Name: COMFORT ELECTRIC SCOOTER, LY-EW408
• Applicant: Comfort Orthopedic Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

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

Device Story

The Comfort Scooter LY-EW408 is a battery-operated, four-wheeled electric scooter designed for indoor and outdoor mobility. The device features a seat mounted on a base and is operated by the rider using hand controls located on the steering column. It is designed to be disassembled for transport and includes an onboard battery charger. The scooter provides mobility to individuals restricted to a seated position, allowing them to navigate environments independently. The operator controls speed via a throttle tiller, enabling adjustment for indoor or outdoor use. The device benefits patients by providing a portable, motorized mobility solution that can be transported in a car trunk.

Clinical Evidence

Bench testing only. Performance validated through EMC testing per ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995. Materials passed resistance ignition testing by SGS.

Technological Characteristics

Four-wheeled electric scooter; battery-operated; hand-controlled steering column; disassemblable frame. Electronic systems (controller, batteries, charger) are UL certified. Back upholstery material tested for ignition resistance. Complies with ANSI/RESNA WC/Vol.2-1998 standards.

Indications for Use

Indicated for persons restricted to a seated 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

• COMFORT SCOOTER LY-EW415 (K063032)

Submission Summary (Full Text)

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## COMFORT ORTHOPEDIC CO., LTD.

www.comfort.com.tw No. 120, Nan Shiang Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R. O. C. 608 TEL : [phone] FAX : [phone]

OCT 3 2007

## દ દ 510(k) SUMMARY "

## Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.

NO. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, 608. TAIWAN, ROC

Date summary prepared:

Device Name:

September 20, 2007

Proprietary Name: Common or Usual Name: Classification Name:

COMFORT SCOOTER, LY-EW408 Electric Scooter Motorized 4-Wheeled Vehicle, Class II, 21 CFR 890.3800

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 COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter 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: COMFORT SCOOTER LY-EW415 (K063032)

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Summary for substantial equivalence comparison:

The overall dimensions and visional appearance are similar, and the dimensions for the new device are smaller than that of the predicate device. The device of the smaller dimensions can be fitted into most of the ordinary car trunk. Thus the new device may be fitted into smaller car trunk. It certainly the new device has more convenient during moving and turning.

The electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Moreover, the suspension of cross brace, footplates, incline degree 12°, armrest type, and warranty are all the same. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.

The maximum speed is 1.0 mph difference for the two devices. The throttle tiller can continuously adjust the speeds. The operators can set the adequate speed according to their feeling and need, i.e., outdoor or indoor, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.

The battery chargers types are almost the same; only for the output electric current is 4A for the new device and 5A for the predicate device. The current differences lead to the charging period differences or arise from the different battery capacity, not related with safety aspect.

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. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Comfort Orthopedic Co., LTD. % ROC Chinese European Industrial Research Society Dr. Jen, Ke-Min No. 58 Fu-Chiun Street Hsin-Chu City, Taiwan, ROC

Re: K072712

Trade/Device Name: Comfort Scooter, LY-EW 408 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 20, 2007 Received: September 25, 2007

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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. Jen, Ke-Min

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 vour device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark M. Melkers

Mark N. Melkerson 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

510 (K) Number ( If Known ): K

Device Name: COMFORT ELECTRIC SCOOTER, LY-EW408

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 NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerin

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number

F1