HAIDA HD21

K082288 · Jiangyin East China Medical Technology Co., Ltd. · ITI · Aug 19, 2008 · Physical Medicine

Device Facts

• Record ID: K082288
• Device Name: HAIDA HD21
• Applicant: Jiangyin East China Medical Technology Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

Device Story

HAIDA HD21 is a battery-operated, motor-driven powered wheelchair designed for indoor and outdoor transportation. It provides mobility for disabled or elderly individuals who are restricted to a seated position. The device functions as a standard powered wheelchair, utilizing battery power to drive motors for user transport. It is operated by the user. The device is intended to improve patient mobility and independence.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and performance characteristics similar to legally marketed predicate devices.

Technological Characteristics

Battery-operated powered wheelchair; indoor/outdoor use; motor-driven; standard powered wheelchair design.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor/outdoor mobility assistance.

Regulatory Classification

Identification

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

Predicate Devices

• CWD01 (K062888)
• KV10HB (K072027)

Submission Summary (Full Text)

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KOr2288

Image /page/0/Picture/1 description: The image shows a logo with a globe-like design. Inside the globe, there are the letters "HD" in a bold, sans-serif font. Below the globe, there are two Chinese characters. The logo appears to be for a company or organization with international connections.

# Jiangyin East China Medical Technology Co., Ltd.

No.555, Qinfeng Road, Huashi Town, Jiangyin City, Jiangsu, China, 214421 TEL: [phone] FAX: [phone]

# 510(k) Summary

AUG 1 9 2008

#### Device

Trade name: HAIDA HD21 powered wheelchair Common name: Powered wheelchair Classification name: Powered wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II

#### Predicate devices

CWD01 (K062888) / EMG Technology Co. Ltd. KV10HB(K072027) / KWANG YANG MOTOR CO., LTD.

#### Intend use of device

HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

## Device description:

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The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.

### Substantial equivalence:

The HAIDA HD21 powered wheelchair is substantially equivalent to the CWD01 (K062888) and KV10HB(K072027) manufactured by EMG Technology Co. Ltd. and KWANG YANG MOTOR CO., LTD., respectively.

There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES.USA

[Image of the Department of Health and Human Services logo]

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jiangyin East China Medical Technology Company., Ltd % Junnata Chang, Ph.D. 14F-2 NO. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220

AUG 1 9 2008

Re: K082288 Trade/Device Name: HAIDA HD 21 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair. Regulatory Class: Class II Product Code: ITI Dated: July 20, 2008 Received: August 11, 2008

Dear Dr. Chang:

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 -- Junnata Chang, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icher will anow you'ls ough miding of substantial equivalence of your device to a legally prematics notification. The stars 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 n you dealte specific an vices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 otification" (21CFR Part 807.97). For questions regarding postmarket surveillance, premance montact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket prease vonace e240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the at (240) the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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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## Statement of Indications for use

510(k) Number (if known): _

Device Name: HAIDA HD21

Indications for use:

It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Over-The-Counter Use ___X Prescription Use __ AND/OR (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, Division of General Division of Generological Devices
and Neurological Devices

Neurologi

510(k) Number K012277

(Posted November 13, 2003)