MODEL 418 SERIES WALKERS

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle. Public Health Service FEB - 8 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mrs. Melly Moroles Chief Financial Officer MJM International Corp. 2003 N. I Road, Suite 10 San Juan, Texas 78589 Re: K053192 Trade/Device Name: Series 400 Walker Regulation Number: 21 CFR 890.3825 Regulation Name: Mechanical walker Regulatory Class: I Exempt Product Code: NXE Dated: November 11, 2005 Received: November 16, 2005 Dear Mrs. Moroles: This letter corrects our letter of December 5, 2005. 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 10 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 mav publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not nean 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 {1}------------------------------------------------ ## Page 2 - Mrs. Moroles forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, signature Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indicat ons for Use 510(k) Number (if known): K053192 Device Name: Series 400 Walker Indications For Use: A mechanical walker used to provide moderate weight support while walking ensuring balance and support. Prescription Use (Part 21 CFR 801 Subpart D) AND ' DR Over-The-Counter Use ਮ (21 CFR 807 Subpart C) (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_________________________________________________________________________________________________________________________________________________________________ Page 1 of _ 6 Received Time Nov 20 1.5KDU