TREVAIR CHAIR

K091478 · Patmont Motor Werks, Inc. · IOR · Jun 18, 2009 · Physical Medicine

Device Facts

• Record ID: K091478
• Device Name: TREVAIR CHAIR
• Applicant: Patmont Motor Werks, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

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.

Device Story

Trevair Chair is a self-propelled, rigid frame, mechanical wheelchair; features large rear wheels with push rims for propulsion and small front pivoting casters for stability. Designed for indoor and outdoor use by physically challenged individuals. Device provides mobility to users with physical limitations. Operation is manual; user-propelled. No electronic or software components.

Technological Characteristics

Mechanical, manual wheelchair; rigid frame construction; features suspension system; large rear wheels with push rims; front pivoting casters. No energy source, 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.

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

# 510(K) SUMMARY

H 775/782.0113

K091478

### SUBMITTER:

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

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:

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

## 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

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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 [phone] or [phone] 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/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