(30 days)
The intended use of Trevair Chair is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use by individuals of all ages who are physically challenged. Designed and handcrafted in Minden Nevada, USA, specifically for any individuals who want or need plush suspension at an uncompromising wheel chair weight.
Trevair Chair is a self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
The provided document is a 510(k) summary for the Trevair Chair, a mechanical wheelchair. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device. The document describes the device, its intended use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission for a traditional medical device like a wheelchair.
Therefore, it is not possible to extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document. The document primarily focuses on regulatory approval based on equivalence to existing devices, not on the performance metrics or validation studies typically associated with AI/ML devices.
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Image /page/0/Picture/0 description: The image shows the logo for "Go-Ped Brand Scooters". The logo is in a bold, sans-serif font, with the words "Go-Ped" stacked on top of "Brand Scooters". The "Go-Ped" part of the logo is larger and more prominent than the "Brand Scooters" part. The logo is black and white, with a thick black outline around the letters.
Patmont Motor
510(K) SUMMARY
H 775/782.0113
SUBMITTER:
Patmont Motor Werks, Inc. 2220 Meridian Blvd. Minden, NV 89423 Phone: (775) 782-0113 x.215 Fax: (775) 783-9004
JUN 18 2009
Steven J. Patmont
May 5th, 2009 DATE:
NAME OF DEVICE:
Trade Name: Trevair Chair Classification Name: Manual Wheelchair - Product Code: IOR
PREDICATE DEVICES:
INTENDED USE:
The intended use of Trevair Chair is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use by individuals of all ages who are physically challenged. Designed and handcrafted in Minden Nevada, USA, specifically for any individuals who want or need plush suspension at an uncompromising wheel chair weight.
DESCRIPTION OF DEVICE:
Trevair Chair is a self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
SUBSTANTIAL EQUIVALENCE:
The Trevair Chair is substantially equivalent to the listed predicate devices in its specifications, performance and use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
JUN 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Patmont Motor Werks, Incomorated % Mr. Steven J. Patmont Chief Executive Officer & Owner 2220 Meridian Boulevard Minden, Nevada 89423
Re: K091478
Trade/Device Name: Trevair Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: June 15, 2009 Received: June 17, 2009
Dear Mr. Patmont:
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 device-related adverse events) (21 CFR 803); good manufacturing
Public Health Service
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Page 2-Mr. Steven J. Patmont
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for "go-ped" brand scooters. The logo is in a bold, sans-serif font, with the words "Brand Scooters" written in a smaller font below. The logo also includes the registered trademark symbol.
Image /page/3/Picture/1 description: The image shows a close-up of a logo or emblem. The logo features a circular design with a complex pattern inside, possibly resembling a snowflake or a stylized flower. There is also some text visible, including the number 775, which may be part of a code or identifier associated with the logo.
782.011
Patmont Motor 30X den. NV 89
INDICATIONS FOR USE
510(K) NUMBER: K091478
DEVICE NAME: Trevair Chair
INDICATIONS OF USE:
The intended use of Trevair Chair is to provide mobility to persons with physical The intended ass of The position. It is intended for indoors and outdoor use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091478
§ 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).