(62 days)
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about a study or acceptance criteria for an AI-powered device. Therefore, I cannot fulfill the request using the provided input.
The document is a standard 510(k) summary for a medical device (a manual wheelchair, Model DS 202-S) establishing substantial equivalence to a predicate device. It details:
- Device Name: DS 202-S manual wheelchair
- Intended Use: To provide mobility to physically challenged persons limited to a sitting position on flat and firm terrain, outdoor or indoor.
- Classification: Class I, Mechanical wheelchair
- Predicate Device: HUADONG HD11 manual wheelchair (K082274)
- Non-Clinical Testing: The device meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec. 5, Sec. 8, Sec. 15, Sec. 15, Sec. 16 and California Bureau of Home Furnishings 117. These standards are for mechanical wheelchair performance and safety.
The request, however, asks for information typically associated with the validation of AI-powered medical devices, including acceptance criteria tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and details of comparative effectiveness studies (MRMC) or standalone performance studies. None of this information is present in the provided text as the device in question is a manual wheelchair, not an AI device.
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SUZHOU KD Medical Appliance Co. Ltd.
No.36, GuGang Rd., ChengXiang Town, TaiCang City, JiangSu Province, China, 215400 TEL: +86-512-53110088 FAX:+86-512-53110099
510(k) Summary
Device
Trade name: DS 202-S manual wheelchair
MAY 2 5 2010
Common name: Manual wheelchair
Classification name: Mechanical wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890,3850
Product Code: IOR
Classification: Class I
Predicate devices
HUADONG HD11 manual wheelchair (K082274)/Jiangyin East China Medical
Technology Co., Ltd
Intend use of device
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Device description:
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and
seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. Substantial equivalence:
The DS 202-S manual wheelchair is substantially equivalent to the legal products. They have the same technological characteristics and intended use of the device.
Non-Clinical testing
The DS 202-S manual wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec. 5, Sec. 8, Sec.15, Sec.15, Sec.16 and California Bureau of Home Furnishings 117.
Conclusion
The DS 202-S manual wheelchair shares performance features and technology with a device already legally marketed within the United States. Therefore, the DS 202-S manual wheelchair is substantially equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SUZHOU KD MEDICAL % International Regulatory Consultant Mr. Jacob Chang 16F-2 (16A) No. 462 SEC 2 Chongde RD BEUITUN DIST Taichung China (Taiwan) 406
MAY 2 5 2010
Re: K100824
Trade/Device Name: Manual Wheelchair, Model DS 202-S Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 12, 2010 Received: March 24, 2010
Dear Mr. 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. 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 - Mr. Jacob Chang
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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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Statement of Indications for Use
510(k) Number (if known):
Device Name: Manual Wheelchair, Model DS 202-S
Indications for Use:
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Over-the-Counter Use _ X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, al.d Restorative Devices
510(k) Number
(Posted November 13, 2003)
§ 890.3850 Mechanical wheelchair.
(a)
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.(b)
Classification. Class I (general controls).