(144 days)
The intended use of Trevair Chair Adult 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 Adult 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 light weight, user adaptable, everyday chair for use both indoors and outdoors.
This document is a 510(k) summary for the Trevair Chair Adult, a manual wheelchair. It does not describe a device that uses artificial intelligence (AI) or machine learning, nor does it present any studies involving acceptance criteria based on performance metrics like sensitivity, specificity, or F1-score.
The document discusses the substantial equivalence of this medical device (a manual wheelchair) to predicate devices, focusing on its specifications, performance, and intended use as required for FDA 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this document does not contain that type of information.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for "go-ped Brand Scooters". The logo is in black and white, with a thick black outline around the letters. The words "Brand Scooters" are in a smaller font size and are located below the "go-ped" part of the logo. There is a registered trademark symbol next to the letter "d".
Patmont Motor W
DEC 1 3 2010
FAX 775/783.9004 PH 775/782.0113 GOPED.COM
510(K) SUMMARY
SUBMITTER:
Patmont Motor Werks, Inc. 2220 Meridian Blvd. Minden, NV 89423 Phone: (775) 782-0113 x.215 Fax: (775) 783-9004
FDA CDRH DMC
JUL 2 2 2010
Steven J. Patmont
Received
DATE: July 12, 2010
NAME OF DEVICE:
Trade Name: Trevair Chair Adult Classification Name: Manual Wheelchair - Product Code: IOR
PREDICATE DEVICES:
INTENDED USE:
The intended use of Trevair Chair Adult 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 Adult 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 light weight, user adaptable, everyday chair for use both indoors and outdoors.
SUBSTANTIAL EQUIVALENCE:
The Trevair Chair Adult is substantially equivalent to the listed predicate devices in its specifications, performance and use.
{1}------------------------------------------------
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 or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
DEC 1 3 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Patmont Motor Werks, Inc. % Mr. Steven J. Patmont 2220 Meridian Boulevard Minden, Nevada 89423
Re: K102061
Trade/Device Name: Trevair Chair Adult Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: November 17, 2010 Received: November 18, 2010
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 indictions 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 Amendonstes, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr w 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, lists in of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and 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, 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
{2}------------------------------------------------
Page 2 - Mr. Steven J. Patmont
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 on medical 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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOffices/ucm1 15809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to prematice of Complex." Also, preat 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson Dec 0.1
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for "Go-Ped Brand Scooters". The logo is in black and white, with the words "Go-Ped" in a stylized font. The words "Brand Scooters" are in a smaller font below the word "Go-Ped". There is a registered trademark symbol to the right of the word "Ped".
Patmont Motor I Minden, NV 89
PH 775/782.0113 FAX 775/783.9004 GOPED.COM
e 12. IE Andria 2017 Version 2012 Carpes on 2012 Corpora de 1028 Chica 2017 C
K10206/
DEC 1 3 2010
INDICATIONS FOR USE
510(K) NUMBER: Unknown at this time
DEVICE NAME: Trevair Chair Adult
INDICATIONS OF USE:
The intended use of Trevair Chair Adult is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
h'Sign-Off) (DIMA Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102061
§ 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).