BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

{0}------------------------------------------------ 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers. Food and Drug Administration 9200 Corporàte Boulevard Rockville MD 20850 NOV 2 0 2003 Besmed Health Business Corporation C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, Taiwan, ROC Re: K031375 Trade/Device Name: Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 4, 2003 Received: September 15, 2003 Dear Dr. Jen: 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 - Ke-Min Jen, Ph.D. 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 (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 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/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}------------------------------------------------ ## 4. INDICATIONS FOR USE STATEMENT | Applicant : | Besmed Health Business Corp. | |-----------------|------------------------------| | 510(k) Number : | TO BE ASSIGNED K031375 | Device Name : Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580 ## Indications for Use : - Specific indications: used to apply an electrical current to electrodes on patient's ● skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion. - Clinical settings: The device should only be used under medical supervisions for ● adjunctive therapy for the treatment of medical diseases and conditions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 OR Over-The-Counter **__** (Optional Format 1-2-96) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number. K031375