(8 days)
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.
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.
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.
The provided text is a 510(k) summary for a powered wheelchair (HAIDA HD21). It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, and product code.
- Predicate Devices: Identifying similar devices already on the market (CWD01 and KV10HB).
- Intended Use: Describing the purpose of the powered wheelchair.
- Device Description: Briefly outlining the design as similar to existing powered wheelchairs.
- Substantial Equivalence: Stating that the HAIDA HD21 is substantially equivalent to the predicate devices and that any minor differences do not raise new safety or effectiveness concerns.
- FDA 510(k) Clearance Letter: Formal approval from the FDA based on the substantial equivalence claim.
- Indications for Use Statement: Detailed description of how the device is intended to be used.
Since the provided text does not describe an active study or acceptance criteria, I cannot fill out the requested table and information. This kind of information is typically found in a "Performance Data" or "Clinical Data" section of a 510(k) submission, which is not present in the provided excerpts.
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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: +86-510-86218310 FAX: +86-510-86218308
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 (240) 276-0120. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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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Pat
Division Sign-Off)
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of General Division of Generological Devices
and Neurological Devices
Neurologi
510(k) Number K012277
(Posted November 13, 2003)
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).