JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP

K051482 · Jan Mao Industries Co., Ltd. · IOR · Jun 29, 2005 · Physical Medicine

Device Facts

• Record ID: K051482
• Device Name: JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP
• Applicant: Jan Mao Industries Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 29, 2005
• 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

Mechanical wheelchair for indoor/outdoor use; provides mobility to individuals restricted to seated position. Features four-wheeled base, foldable frame, sling-style seat/back upholstery. Includes removable desk-length armrests and swing-away detachable elevating footrests. Operated by user or caregiver. Upholstery meets CAL 117 flame retardant standards. Device facilitates patient mobility and independence.

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 frame; sling-type seat/back upholstery meeting CAL 117 flame retardant standards. Features removable desk-length armrests and swing-away detachable elevating footrests. 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

• AVANTICARE Mechanical Wheelchair, MR-9000 (K050708)

Submission Summary (Full Text)

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K051482 JUN 2 9 2005 1/2

JMe
ISO 9000
進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
1F. No. 22 Alley 20 Lanc142. Sec. 6. Roosevelt Rd..
Wen-Shar Dist., Taiper. Taiwan, R. O. C.
TEL: [phone] FAX: [phone]
E-mail Address: [e-mail]

## 510(k) SUMMARY "

Submitter's Name: JAN MAO INDUSTRIES CO., LTD. No.181, Chu Liao Road, Ta Su Hsiang, Kao Hsiung Hsian, TAIWAN, 840, ROC

Date summary prepared:

Device Name:

Proprietary Name:

Common or Usual Name: Classification Name:

May 27, 2005

JAN MAO. Wheelchair, JMC612-F18EPP 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 JAN MAO Wheelchair, JMC612-F18EPP 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:

JAN MAO Wheelchair, JMC612-F18EPP meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison:

AVANTICARE Mechanical Wheelchair, MR-9000 ( K050708 )

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K051482

Me 進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
ISO 9002

17. No. 22. Alley 20 Lane142. Sec. 6. Roosevelt Rd.
Wen-Soar Dist., Taipei, Taiwan. R. O. C.
TEL: [phone] FAX: [phone]
E-mail Address: [e-mail]

2/2

Summary for substantial equivalence comparison:

The new device and the predicate device have the same intended use Mainframes of two devices are foldable. The overall dimensions are similar and same weight capacity. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The major differences existing are the overall dimension. Besides, the predicate device is fixed frame and the new device is removable desk-length armrest and swing-away detachable elevating footrest. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/13 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines above two wavy lines.

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jan Mao Industries Company, Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300

Re: K051482

Trade/Device Name: JAN MAO, Wheelchair JMC612-F18EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 27, 2005 Received: June 3, 2005

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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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/industry/support/index.html.

Sincerely yours,

Stupt Charles

iam C. Provost, Ph.D. Acting 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: JAN MAO, Wheelchair JMC612-F18EPP

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)

Hyet Murda
(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative. and Neurological Devices

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510(k) Number K051482