MODEL BMLS03-7

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAR 1 4 2005 Mr. Gary Bussett Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085 Re: K042711 Trade/Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7 Regulation Numbers: 21 CFR 890.5850, 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, and interferential current stimulator. Regulatory Class: II Product Code: IPF, GZJ, LIH Dated: February 23, 2005 Received: February 25, 2005 Dear Mr. Gary Bussett: 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 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 – Mr. Gary Bussett This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The Pro on 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 If you desire specific advision at (240) 276-0120 . Also, please note the regulation entitled, Colliact the Office of Compullinemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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, L. Marlin A. Millikenn Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE KOYZZIL 510(k) Number (if known): Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Combination Transculatiedus Liectivel Norvo Gilhalator North Stimulator, Model BML S03-7 ### Indications for Use: # (TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of nort surgical and Transcutaneous Electived Nerve Stimulation (TENO) is about the Symbon. chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical post-traumatic acute pain problems. ### Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: External electrical neuromuscular sumulation asing expractic e a pasm; muscle reculture, prevention of relariation of muscle disuse atrophy, roluxation of model of model on and as immediate mailitaining and increasing the range of event venous thrombosis. #### Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an Interential Summation is used for Symptomation rates and post-fraumatic acute pain. ### High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of High Voltage Pulsed Stimulation is Indicated as moralisation maintaining and increasing the range of disuse attophy, relaxation of muscle spash, music roodbated manaly and muscles to prevent venous thrombosis. 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) Mark N. Wilkerson 510(k) Number K042711