GENEMAX POWER WHEELCHAIR, PW4

K042749 · Genemax Medical Products Industry Corp. · ITI · Nov 12, 2004 · Physical Medicine

Device Facts

• Record ID: K042749
• Device Name: GENEMAX POWER WHEELCHAIR, PW4
• Applicant: Genemax Medical Products Industry Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 12, 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

Genemax PW4 is battery-operated indoor/outdoor powered wheelchair; provides mobility for individuals restricted to seated position. Features four-wheeled base with seat; rider-operated via hand controls on steering column. Device is collapsible for transport; includes onboard battery charger. Used in various environments by patients requiring mobility support. Electronic systems, including controller, batteries, and charger, are UL-certified. Output is physical mobility; enables independent navigation for 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 electronic systems, controllers, and chargers.

Technological Characteristics

Battery-operated powered wheelchair; four-wheeled base. Electronic controller, batteries, and charger are UL-certified. Materials for back upholstery passed resistance ignition testing (SGS). Dimensions and weight limits vary from predicate. Connectivity: None. Energy source: Battery.

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 Power Wheelchair, TL-320 (K022697)

Submission Summary (Full Text)

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K042749

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NOV 1 2 2004

Genemax Medical Products Industry Corp.

No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel. [phone] - Fax: [phone] [e-mail]

## 510(k) SUMMARY " 66

Submitter's Name: Genemax Medical Products Industry Corp. No. 86, Lane 226, Tai-Ming Rd., Wu-Jih Taichung, 414, Taiwan, R.O.C.

Date summary prepared:

September 28, 2004

Device Name:

| Proprietary Name: |
|-----------------------|
| Common or Usual Name: |
| Classification Name: |

Genemax Power Wheelchair, PW4 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.

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Description of the device:

The Genemax Power Wheelchair, PW4 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 Power Wheelchair, TL-320 (K022697)

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## Genemax Medical Products Industry Corp.

No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel: [phone] Fax: [phone] 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 incline, removable arm type, and back upholstery are the same material that also be passed the resistance ignition test The major differences existing of the two Power Wheelchairs are the by SGS. different overall dimension and weight limit between the two devices. The overall appearance and weight differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Genemax Medical Products Industry Corp. C/o Dr. Jen Ke-Min Roc Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K042749

Trade/Device Name: GENEMAX Power Wheelchair, PW4 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 29, 2004 Received: October 4, 2004

Dear Ke-Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device n & neve rowled 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 for doe career in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 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 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. Millhussen

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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## Indications for Use

K042749 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: GENEMAX Power Wheelchair, PW4

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**

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510(k) Number: K042749