JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP

K062218 · Jan Mao Industries Co., Ltd. · IOR · Aug 16, 2006 · Physical Medicine

Device Facts

• Record ID: K062218
• Device Name: JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
• Applicant: Jan Mao Industries Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Aug 16, 2006
• 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 mainframe, standard sling-type seat/back, removable desk-length armrests, and swing-away detachable elevating footrests. Operated by user or caregiver. Device is manually propelled; no electronic or software components. Benefits include improved patient mobility and transportability via foldable design.

Clinical Evidence

Bench testing only. Device meets ANSI/RESNA WC vol. 1 and ISO 7176 wheelchair standards.

Technological Characteristics

Mechanical wheelchair; foldable mainframe; sling-type seat/back; upholstery meets CAL 117 flame retardant standards. Complies with ANSI/RESNA WC vol. 1 and ISO 7176 standards. No electronic components, software, or power source.

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

• JAN MAO Wheelchair JMC612-F18EPP (K051482)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters "JMC" stacked on top of each other. The letters are in a bold, sans-serif font and appear to be slightly distressed or textured. Below the logo, the text "ISO 9002" is printed in a smaller, simpler font. The overall image has a grainy or low-resolution quality.

## JAN MAO INDUSTRIES CO., LTD.

1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:[phone] Fax: [phone] E-mail: [e-mail]

K062218

#### દ્ધ 510(k) SUMMARY '

AUG 16 2006

Submitter's Name: JAN MAO INDUSTRIES CO., LTD. No.181, Chu Liao Road, Ta Su Hsiang, Kao Hsiung Hsian, TAIWAN, 84045, ROC

Date summary prepared:

July 25, 2006

Device Name:

Proprietary Name:

Classification Name:

JAN MAO, Wheelchair, JMC612-FL318EPP, JMC612-FL418EPP Common or Usual Name: 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-FL318EPP(& JMC612-FL418EPP)is 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-FL318EPP ( & JMC612-FL418EPP ) 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: JAN MAO Wheelchair JMC612-F18EPP ( K051482 )

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Image /page/1/Picture/0 description: The image shows a logo with the letters "JMC" stacked on top of each other. The letters are in a bold, sans-serif font. Below the logo, the text "ISO 9002" is printed in a smaller font. The image has a grainy texture, suggesting it may be a scan or photocopy.

# JAN MAO INDUSTRIES CO., LTD. 1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:[phone] Fax: [phone] E-mail: [e-mail]

Summary for substantial equivalence comparison:

From the above comparison table the predicate device (JMC612-F18EPP, K051482) and new devices (JMC612-FL318EPP & JMC612-FL418EPP) are the same. JMC612 series products. The intended use between the predicate device and new devices are the same. Mainframes of two devices are foldable. The overall dimensions are similar and the same weight capacity, same removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 1 6 2006

JAN MAO INDUSTRIES CO., LTD. % Roc Chinese - European Industrial Dr. Ke-Min Jen No. 58 Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K062218

Trade/Device Name: JAN MAO Wheelchair, JMC612-FL318EPP, JMC612-FK418EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: July 25, 2006 Received: August 1, 2006

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/industry/support/index.html.

Sincerely yours,

for Blo Thurnett / ASSAY

Mark N. Melkerson 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 a logo with the letters "JMC" stacked vertically. Below the logo, the text "ISO 9002" is displayed. The logo and text are rendered in black and white, with a slightly grainy or textured appearance.

JAN MAO INDUSTRIES CO., LTD. 1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:[phone] Fax: [phone] E-mail: [e-mail]

# Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: JAN MAO Wheelchair, JMC612-FL318EPP, JMC612-FL418EPP

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) |
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V. Othmer

Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K062218