HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Jen. Ke-Min Home Care Technology Co., Ltd. 116, Lane 523, Sec. 3 Jung Jeng Road Jen Ter Hsiang Tainan Hsien, Taiwan ROC 717 APR 0 8 2003 Re: K023001 Trade/Device Name: Homecare HT-326L Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: Class II Product Codes: IPF Dated: December 31, 2002 Received: January 8, 2003 Dear Dr. Jen, Ke-Min: 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 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 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 {1}------------------------------------------------ Page 2 - Dr. Jen, Ke-Min 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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. L. Mach X. Mellems 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: K023001 Applicant: Home Care Technology Co., Ltd. Device Name: Home Care HT-326L Indications For Use: Specific Indications: Used to apply an electrical current to electrodes on patients 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 supervision for adjunctive therapy for the treatment of medical diseases and conditions. Concurrence of CDRH, Office of Device Evaluation (ODE) | | <i>for</i> (Division Sign-Off) Division of General, Restorative and Neurological Devices | |---------------|----------------------------------------------------------------------------------------------| | 510(k) Number | K02300 | | Prescription Use<br>(Per 21 CFR 801-109) | OR | Over-The-Counter | |------------------------------------------|----|------------------| |------------------------------------------|----|------------------|