(233 days)
The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for various models of wheelchairs, confirming their substantial equivalence to predicate devices and outlining regulatory requirements. It does not include details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 16, 2013
Sunrise Medical LLC c/o Laurie Roberts. Senior Manager - Regulatory Affairs 2842 Business Park Ave. Fresno, CA 93727-1328
Re: K123975
Trade/Device Name: Quickie 2. Quickie 2 HD. Quickie GT, Quickie IRIS, Zippie IRIS. Quickie LXI, Quickie QRi, and Quickie Q7 Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 22, 2013 Received: July 23, 2013
Dear Ms. Roberts:
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, and 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); medical device reporting (reporting of medical
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Page 2 - Ms. Laurie Roberts
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K123975
Device Name: Quickie 2, Quickie 2 HD, Quickie GT, Quickie IRIS, Zippie IRIS, Quickie LXI, Quickie QRi, and Quickie Q7 Wheelchairs
Indications For Use:
The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123975
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§ 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).