KARMA POWER WHEELCHAIR, MODEL KP-25

K041678 · Karma Medical Products Co., Ltd. · ITI · Jul 23, 2004 · Physical Medicine

Device Facts

• Record ID: K041678
• Device Name: KARMA POWER WHEELCHAIR, MODEL KP-25
• Applicant: Karma Medical Products Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 23, 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 controls movement via hand controls on steering column. Disassemblable for transport; includes onboard battery charger. Used in home or community settings by patients with mobility restrictions. Provides independent mobility to the user.

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 powered wheelchairs, controllers, and chargers. Upholstery material passed resistance ignition testing per SGS standards.

Technological Characteristics

Battery-operated powered wheelchair. Four-wheeled base. Hand-controlled steering column. Foldable frame. Removable armrests. Electronic controller, batteries, and charger are UL-certified. Upholstery material tested for ignition resistance.

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

• SINON Power Wheelchair, SN-W401 (K040319)

Submission Summary (Full Text)

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Image /page/0/Picture/20 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in a bold, sans-serif font, with a heart shape replacing the letter "A". Above the heart is a small, stylized wing. Below the word "Karma" is the phrase "home & health care" in a smaller, thinner font.

JUL 2 3 2004

KARMA MEDICAL PRODUCTS CO., LTD. 康揚股份有限公司 U.K. U.S.A. TAIWAN THAI. Tel:[phone] Fax:[phone] Http://www.KarmaMedical.com K041678 E-mail:[e-mail]

June 13, 2004

## દ્ધ 510(k) SUMMARY "

## 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.

Date summary prepared:

Device Name:

Proprietary Name:

KARMA Power Wheelchair, KP-25

Common or Usual Name: Classification Name:

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 KARMA Power Wheelchair, KP-25 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: SINON Power Wheelchair, SN-W401 (K040319)

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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 large, bold letters, with a heart shape replacing the letter "M". A small wing is attached to the top right of the heart. Below the word "Karma", the words "home & health care" are written in a smaller font.

KARMA MEDICAL PRODUCTS CO., LTD. 康 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]

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge, switches & switching power supplies. Thus the same safety level for the two devices is assured. 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 Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. TThus 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 and 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 an eagle or bird in flight, composed of three curved lines.

Public Health Service

'JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K041678

Trade/Device Name: KARMA Power Wheelchair, KP-25 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 13, 2004 Received: June 21, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 976, the enactment date of the Medical Device Amendments, or to conniner of Price to Frid) 20, 2017, in accordance with the provisions of the Federal Food, Drug, de rices that have been that do not require approval of a premarket approval application (PMA). and Cosmetic For (11er) that as nevice, subject to the general controls provisions of the Act. The I va may, diereleve, mains of the Act include requirements for annual registration, listing of general bonurols profiseving 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 may or defect to deal 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 or uny I 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 orth 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) This letter with anow you to ogin maneting of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific arroliance at [phone]. Also, please note the regulation entitled, oonlaet the Office of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 N Milliken

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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Image /page/4/Picture/0 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in large, bold, sans-serif font. Below the word "Karma" is the phrase "home & health care" in a smaller, lighter font. To the right of the word "Karma" is a heart with a wing attached to it.

KARMA MEDICAL PRODUCTS CO., LTD. 康揚股份有限公司 U.K. U.S.A. TAIWAN THAI. Tel:[phone] Fax:[phone]

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

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510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: KARMA Power Wheelchair, KP-25

INDICATIONS FOR USE:

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

Mark A Milkers

Division of General, Restorative, and Neurological Devices

**510(k) Number** K041678

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)