KARMA SCOOTER, MODEL KS-747.2

K041677 · Karma Medical Products Co., Ltd. · INI · Aug 5, 2004 · Physical Medicine

Device Facts

• Record ID: K041677
• Device Name: KARMA SCOOTER, MODEL KS-747.2
• Applicant: Karma Medical Products Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• 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, 4-wheeled powered scooter; provides mobility for individuals restricted to seated position. Rider operates via hand controls on steering column. Device features foldable frame, removable armrests, and onboard battery charger. Used in indoor/outdoor environments. Output is physical mobility for the user. Differences in overall dimensions and weight compared to predicate do not impact safety.

Clinical Evidence

Bench testing only. Compliance with EMC standards ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995. Back upholstery material passed resistance ignition testing by SGS.

Technological Characteristics

4-wheeled powered scooter; battery-operated. Features foldable frame, removable armrests, and hand-operated steering column controls. Electronic systems (batteries, chargers, controllers) are UL-certified. Complies with ANSI/RESNA WC/Vol.2-1998 and relevant IEC/CISPR EMC 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

• WELL SUCCESS A&I Scooter, SC-402 (K041193)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "AUG - 5 2004" on the top left corner. To the right of the date is the logo for Karma home & health care. The logo includes the word "KARMA" in bold, black letters, with the words "home & health care" in a smaller font below. There is also a heart with a wing above the letter "M" in Karma.

## KARMA MEDICAL 康揚股份有限公司 Tel:[phone] Fax:[phone]

Http://www.KarmaMedical.com E-mail:[e-mail]

## 510(k) SUMMARY " દ્ધ

Submitter's Name: KARMA Medical Products Co., Ltd.

No. 2363, Sec.2, Da-Shiue Road, Min-Hsiung Shiang, Chia-Yi Hsien, 621, Taiwan, R.O.C.

June 14, 2004

Date summary prepared:

Device Name:

Proprietary Name:

KARMA Scooter, KS747.2

Common or Usual Name: Classification Name:

Electrical 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 KARMA Scooter KS747.2 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.

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)

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Image /page/1/Picture/0 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in a bold, serif font. A heart shape with a swirl inside replaces the letter "A" in "Karma". A wing-like design is attached to the upper right side of the heart. Below "Karma" is the phrase "home & health care" in a smaller, sans-serif font.

KARMA MEDICAL PRODUCTS CO., LTD. 康揚 揚 股 份 有 限 公 司 U.K. U.S.A. TAIWAN THAI. Tel:[phone] Fax:[phone] Http://www.KarmaMedical.com E-mail:[e-mail]

Legally marketed device for substantial equivalence comparison: WELL SUCCESS A&I Scooter, SC-402 (K041193)

Summary for substantial equivalence comparison:

The intended uses, the size of tires, back upholstery, and warranty period between the new device KS747.2 and the predicate device SC-402 are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Besides, the two devices are the same foldable frame, maximum speed, removable arm type, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS. The major differences existing of the two Powered Scooters are the different overall dimension and weight 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines emanating from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG = 5 2004

KARMA Medical Products Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K041677

Trade/Device Name: KARMA Scooter, KS-747.2 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 14, 2004 Received: June 21, 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.

Sincerely, yours,

Mark A. Mcllhennon

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: KARMA Scooter, KS-747.2

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)

Afcurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

K041677

510(k) Number