TRAXX ELECTRIC WHEELCHAIR

K022194 · Crossroads Distribution Company, LLC · ITI · Oct 29, 2002 · Physical Medicine

Device Facts

• Record ID: K022194
• Device Name: TRAXX ELECTRIC WHEELCHAIR
• Applicant: Crossroads Distribution Company, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Traxx Electric Wheelchair is a battery-operated device that is intended to provide mobility for people with a disability.

Device Story

Traxx Electric Wheelchair is a battery-operated mobility device designed for individuals with disabilities. It functions as a powered wheelchair to provide independent mobility. The device is intended for use by patients in various settings, including home and community environments. It operates via standard electric wheelchair controls, allowing the user to navigate and maneuver. The device benefits the patient by restoring or enhancing mobility, facilitating daily activities, and increasing independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated powered wheelchair; Class II device; Product Code ITI; Regulation 890.3860.

Indications for Use

Indicated for individuals with disabilities requiring mobility assistance via a battery-operated powered wheelchair.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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, composed of three curved lines, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

OCT 2 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Crossroads Distribution Company, L.L.C. c/o Regulatory Insight, Inc. Kevin Walls 13 Red Fox Lane Littleton, Colorado 80127

Re: K022194

Trade/Device Name: Traxx Electric Wheelchair Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: October 8, 2002 Received: October 9, 2002

Dear Mr. Walls:

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. Iisting 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 systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Mr. Kevin Walls

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

L. M. A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 510(k) Number (if known):

Device Name: Traxx Electric Wheelchair

Indications for Use: The Traxx Electric Wheelchair is a battery-operated device that is intended to provide mobility for people with a disability.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _

Prescription Use × (Per 21 CFR 801.109)

L. Miel. A. Millaire.

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510 Number KC 2.)194