(73 days)
The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch designed for an adult occupant that wrighs up to 215 pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard
Powered wheelchair
The provided text is a 510(k) clearance letter from the FDA for a power wheelchair, Mobilife Model (Mobil Raizer 22). This document focuses on the regulatory clearance process for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
Therefore, I cannot answer your request based on the provided text. The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, etc.) are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
MobiLife, LLC. c/o Mr. Steven DuFresne President 78 Enterprise Road, Unit D Delafield, Wisconsin 53018
Re: K061116
Trade/Device Name: MobiLife - Model (Mobil Raizer 22) - Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 23, 2006 Received: June 23, 2006
Dear Mr. DuFresne:
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 reclass:tied 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 mav. 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
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Page 2 - Mr. Steven DuFresne
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Preem
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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Indications for Use
510(k) Number (if known): K061116 Mobilife - Model ( Mobil Raizer 22) -Device Name: Wheel chuir Vower Indications For Use: The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch occupant that wrighs up to 215 designed for an adult pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Us . (21 CFR 807 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bartare Buehm
Division Sign-Of Division of General, Restorative, and Ncurological Devices
510(k) Number K061116
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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).