KAIYANG ALUMINUM WHEELCHAIR

K101998 · Guangdong Kaiyang Medical Technology Co., Ltd. · IOR · Oct 4, 2010 · Physical Medicine

Device Facts

• Record ID: K101998
• Device Name: KAIYANG ALUMINUM 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

Intended Use

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

Device Story

KAIYANG Aluminum Wheelchair is a manual, foldable, four-wheeled mechanical wheelchair for indoor/outdoor use. Device features a standard sling-type seat and backrest with flame-retardant upholstery (CAL 117). Includes removable desk-length armrests and swing-away detachable elevating footrests. Designed for mobility support for individuals restricted to a seated position. Operated by the user or an assistant; no electronic or software components.

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; aluminum frame; sling-type seat/backrest; upholstery meets California Technical Bulletin CAL 117 flame retardant standards. Complies with ANSI/RESNA WC vol. 1 and ISO 7176 standards. No electronic components, software, or energy 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-FL318EPP & JMC612-FL418EPP (K062218)

Submission Summary (Full Text)

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## Guangdong Kaiyang Medical Technology Co., Ltd.

Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 B

Tel: [phone] Fax:[phone] Email:[e-mail]

OCT 4 2010

## 510(k) SUMMARY "

Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231

Date summary prepared:

June 21, 2010

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

KAIYANG Aluminum 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 KAIYANG Aluminum Wheelchair 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:

Wheelchair the applicable performance KAIYANG Aluminum meets 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-FL318EPP & JMC612-FL418EPP (K062218 )

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Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231 Tel: [phone] Fax:[phone] Email:[e-mail]

Summary for substantial equivalence comparison:

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

From the above comparison table the intended use between the predicate device and new devices are the same. 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 overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.

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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

OCT 4 2000

Re: K101998

Trade/Device Name: KAIYANG Aluminum 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,

for

Mark N. Melin

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 Aluminum Wheelchair

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)

productions and this and world and world be one in the with the with the with the with the with the with the with the with the with the with the with the with the with the wi

Division Sign-Off

(Division Sign. (Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K101998