KAIYANG STEEL WHEELCHAIR

K101999 · Guangdong Kaiyang Medical Technology Co., Ltd. · IOR · Oct 4, 2010 · Physical Medicine

Device Facts

• Record ID: K101999
• Device Name: KAIYANG STEEL WHEELCHAIR
• Applicant: Guangdong Kaiyang Medical Technology Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

KAIYANG Steel Wheelchair is a manual, four-wheeled indoor/outdoor mobility device. Features include a foldable steel frame, standard sling-style seat and back upholstery, removable desk-length armrests, and swing-away detachable elevating footrests. Designed for transportability via disassembly and folding. Operated by the user or an assistant to provide mobility for individuals restricted to a seated position.

Clinical Evidence

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

Technological Characteristics

Steel frame construction; foldable design; four-wheeled base; 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

• JMC612-FL318EPP
• JMC612-FL418EPP

Submission Summary (Full Text)

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## Guangdong Kaiyang Medical Technology Co., Ltd.,

China guồng Trai young
Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 h Tel: [phone] Fax:[phone] Email:[e-mail]

**OCT 4 2010**

## 510(k) SUMMARY "

Y”
K101999

Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. , Grangaong Tulyang Dali, Nanhai District, Foshan, China, 528231

July 2, 2010

Date summary prepared:

Device Name:

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

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

Performance Testing:

KAIYANG Steel Wheelchair 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:

hairean- --------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Summary for substantial equivalence comparison:

From the above comparison table the intended use between the predicate devices (JMC612-FL318EPP and JMC612-FL418EPP) are the identical structure but made by different materials, steel for JMC612-FL318EPP and aluminum for JMC612-FL418EPP; and new device is made by steel structure. Mainframes of two devices are foldable. There are similar 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 standard for flame retardant. The C overall appearance differences are not safety aspect. Thus 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 U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Guangdong Kaiyang Medical Technology Co., Ltd. % Dr. Ke-Min Jen Official Correspondent Yanfeng Industrial Area, Dali, Nanhai District Foshan China 528231

4 2010 OCT

Re: K101999

Trade/Device Name: KAIYANG Steel Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 17, 2010 Received: August 25, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Dr. Ke-Min Jen

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________

Device Name: _KAIYANG Steel Wheelchair_

Indications for Use:

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

Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
S IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Surgical, Orthopedic,
and Restorative Devices

| 510(k) Number | K101999 |
|---------------|---------|
|---------------|---------|

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