PRO WALKER ML-300 FOLDABLE WHEELCHAIR

K041337 · Pro Walker, Inc. · IOR · May 28, 2004 · Physical Medicine

Device Facts

• Record ID: K041337
• Device Name: PRO WALKER ML-300 FOLDABLE WHEELCHAIR
• Applicant: Pro Walker, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

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

Device Story

PRO WALKER ML-300 is a manual, foldable, indoor/outdoor mechanical wheelchair; provides mobility for individuals restricted to seated position. Features four-wheeled base, standard sling-type seat and back upholstery. Device is foldable and can be disassembled for transport. Operated by user or caregiver; no electronic or powered components. Benefits include improved patient mobility and ease of transport.

Clinical Evidence

Bench testing only. Device meets performance requirements specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Technological Characteristics

Mechanical wheelchair; foldable mainframe; sling-type seat/back upholstery meeting California Technical Bulletin CAL 117 flame retardant standards. Complies with ANSI/RESNA WC vol. 1 and ISO 7176 standards.

Indications for Use

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

Regulatory Classification

Identification

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• BIOTECH B900 SUPER LIGHT Wheelchair (K020472)

Submission Summary (Full Text)

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K041337

MAY 2 8 2004

Image /page/0/Picture/2 description: The image shows a logo with the text "PRO WALKER" below a stylized letter "P". The "P" is bold and angular, with a horizontal line running through the upper portion, resembling a wave or a stylized design element. The text "PRO WALKER" is in a simple, sans-serif font, positioned directly beneath the "P" logo.

60. An Li Lane, Chang An Rd., Tachia, Tai ien. TAI WAN. K. Fax: [phone] Vebsite: www.pro-walker.com.tw E-mail : [e-mail]

### 510(k) SUMMARY " દ દ

Submitter's Name: PRO WALKER INC. No. 60, An Li Lane, Chang An Road, Tachia, Taichung Hsine,

Taiwan, 437, ROC.

May 12, 2004

Device Name:

Date summary prepared:

Proprietary Name:

Common or Usual Name: Classification Name:

PRO WALKER ML-300 Foldable Wheelchair Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850

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 PRO WALKER ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Performance Testing:

ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards as indicated in section B page 7-1~7-5.

Legally marketed device for substantial equivalence comparison: BIOTECH B900 SUPER LIGHT Wheelchair ( K020472 ).

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Image /page/1/Picture/0 description: The image shows a logo with the text "PRO WALKER" below a stylized letter "P". The "P" is designed with a thick, bold line and has a wave-like shape inside the upper loop. The text "PRO WALKER" is in a simple, sans-serif font and is aligned below the left side of the "P".

60, An Li Lane, Chang An Rd., Tachia, Taichung sien. TAI WAN. R.O. Tel: [phone] Fax: [phone] Website: www.pro-walker.com.tw E-mail : [e-mail]

Summary for substantial equivalence comparison:

The new device and the predicate device have the same intended use and the weight limit 100kgs between the two devices is the same. Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance ignitability fabric. - The major differences existing of the two Mechanical Wheelchairs 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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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 8 2004

Pro Walker, Inc. C/o Dr. Kc-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Rc: K041337

Trade/Device Name: PRO WALKER ML-300 Foldable Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 12, 2004 Reccived: May 19, 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,

Mark A. Milkerer

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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# 510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: PRO WALKER ML-300 Foldable Wheelchair

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to person 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 Marathon (ODE)

for Mark
(Division Sign-Off)
Division of General, Ranterative,
and Neurological Devi...

510 K041337