INTERFERENTIAL STIMULATOR, MODEL BMLS02-6

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol used by the U.S. government. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 7 2004 Richard Saxon President Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360 Re: K040007 Trade/Device Name: Interferential Stimulator, Model BMLS02-6 Regulation Number: Unclassified Regulation Name: Interferential stimulator Regulatory Class: Unclassified Product Code: LIH Dated: June 17, 2004 Received: June 18, 2004 Dear Mr. Saxon: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovened your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreated of the enactment date of the Medical Device Amendments, or to eoniner of the ria) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and coometre fore, market the device, subject to the general controls provisions of the Act. The I ou may) ateres, 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 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 (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ ## Page 2 - Richard Saxon This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and by of substantial equivalence of your device of your device to a legally premaince motive 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 11 you a sen o spee of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marce facturers, 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/dsma/dsmamain.html Sincerely yours, Miriam C. Provost 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): K040007 Device Name: Interferential Stimulator Model BMLS02-6 Indications for Use: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or mierelefitial Olimbiation is used for bymptomatic followical and post-traumatic acute pain. Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21CFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost Division of General, Restorative, and Neurological Devices 510(k) Number K040007 Page 1 _ of __ 1