TREVAIR CHAIR ADULT

K102061 · Patmont Motor Werks, Inc. · IOR · Dec 13, 2010 · Physical Medicine

Device Facts

• Record ID: K102061
• Device Name: TREVAIR CHAIR ADULT
• Applicant: Patmont Motor Werks, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Dec 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

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.

Device Story

Trevair Chair Adult is a self-propelled, rigid-frame, mechanical wheelchair. Device features large rear wheels with push rims for manual propulsion and small front pivoting casters for stability and turning. Designed for indoor and outdoor use by individuals with physical limitations. Device provides mobility assistance to the user. Operation is entirely manual; no electronic or powered components. User-adaptable design focuses on providing suspension while maintaining low weight. Healthcare providers or patients use the device to facilitate independent movement for those with mobility impairments.

Clinical Evidence

No clinical data provided; device is a mechanical manual wheelchair.

Technological Characteristics

Mechanical, rigid-frame manual wheelchair. Features large rear wheels with push rims and front pivoting casters. Includes suspension system. Non-powered, manual operation. No software or electronic components.

Indications for Use

Indicated for individuals of all ages with physical limitations requiring a sitting position for mobility. Intended for indoor and outdoor use. No specific contraindications listed.

Regulatory Classification

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.

Predicate Devices

• Per4maX Medical, LLC Shockwave Suspension Wheelchair (K032123)
• Colours Boing (K945534)

Submission Summary (Full Text)

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Patmont Motor W

DEC 1 3 2010

FAX [phone] PH 775/782.0113 GOPED.COM

# 510(K) SUMMARY

SUBMITTER:

Patmont Motor Werks, Inc. 2220 Meridian Blvd. Minden, NV 89423 Phone: [phone] x.215 Fax: [phone]

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:

- 1) Per4maX Medical, LLC Shockwave Suspension Wheelchair K032123
- 2) Colours Boing K945534

### 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.

-

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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

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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 [phone] or [phone] 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

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Patmont Motor I Minden, NV 89

PH 775/782.0113 FAX [phone] GOPED.COM

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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