(144 days)
The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.
Breeze C, 3&4 wheels Scooter
This is an FDA 510(k) clearance letter for a medical device (Breeze C, 3&4 wheels Scooter), not a study report or clinical trial
document. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study
details, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather
than proving performance against specific acceptance criteria through a clinical study as would be detailed in a separate
performance testing report or clinical trial submission.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH &" are arranged vertically on the left side of the logo, and the words "HUMAN SERVICES" are arranged vertically on the right side of the logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Afikim Electric Vehicles % Mr. Avner Fishbein R&D Manager Kibbutz Alikim lsrael 15148
JAN - 7 201
Re: K102304 Trade/Device Name: Breeze C Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: November 22, 2010 Received: November 22, 2010
Dear Mr. Fishbein:
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 the Pederal Food, Drig,
You may, therefore, market the desires 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 of crimes of teast in (17WA).
found in the Gods of Existing I Development 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 Megister.
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 – Mr. Avner Fishbein
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/ReportalProblem/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,
Rdr
ark N. Malkerian
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
JAN - 7 2011
510(k) Number (if known): K102304
Device Name: Breeze C
Indications for Use:
The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons.
The Breeze is also suite for the use of elderly persons and physically disabled persons.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ V AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102304
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).