(71 days)
Intended use is attendant guided transportation for hospital patients. Amigo Mobility International's intent is to supply the above named device to hospital equipment distributors. The device can be operated indoors on carpeting, linoleum, and other floors, and on sidewalks.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the Amigo Escort 7.5 powered wheelchair does not contain the information requested in your prompt.
The document is a substantial equivalence determination letter, which confirms that the FDA has reviewed the premarket notification for the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies general controls, regulatory class, and lists the indications for use.
However, it does not include details about:
- Acceptance criteria and reported device performance in a table format.
- Sample sizes, data provenance, or details about the test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance studies.
- Type of ground truth used (expert consensus, pathology, outcome data).
- Training set sample size or how its ground truth was established.
This type of information, particularly regarding detailed performance studies, would typically be found in the 510(k) submission itself, which is a much more extensive document than the FDA's decision letter.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 · Silver Spring, MD 20993-0002
DEC - 4 2009
Amigo Mobility International, Inc. % Mr. Mike LaBrake Director of Operations 6693 Dixie Highway Bridgeport, Michigan 48722
Re: K092936
Trade/Device Name: Amigo Escort 7.5 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 6, 2009 Received: November 12, 2009
Dear Mr. LaBrake:
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 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); medical device reporting (reporting of medical
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Page 2 - Mr. Mike LaBrake
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
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
510(k) Number (if known): K092936
Device Name: Amigo Escort 7.5
Indications For Use: Intended use is attendant guided transportation for hospital patients. Amigo Mobility International's intent is to supply the above named device to hospital equipment distributors. The device can be operated indoors on carpeting, linoleum, and other floors, and on sidewalks.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use . (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOHTER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K09292
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§ 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).