KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138

{0}------------------------------------------------ K062453 ## 5. SUMMARY OF SAFETY AND EFFECTIVENESS ( According to 21 CFR 807.92) APR 1 7 2007 DATE OF SUBMISSION: August 5, 2006 SUBMITTER: President, Chin Lin Huang KINGLY STAR INTL. TECHNOLOGY CO., LTD. No. 168, Changshuei Road, Changhua City, 50071, Taiwan, ROC TEL: 886-4-7636262 FAX: 886-4-7631621 ESTABLISHMENT REGISTRATION NO: 9612742 OFFICIAL Dr. JEN, KE-MIN CONTACT: ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: 886-3-5208829 FAX:886-3-5209783 TRADE NAME: KINGLY STAR Powered Muscle Stimulator, KS-138 COMMON/USUAL Electrical Muscle Stimulator NAME: Powered Muscle Stimulator CLASSIFICATION REGULATION 890.5850 NUMBER: PREDICATED DEVICE: TAI SHENG Powered Muscle Stimulator, TS-166, (K031310) INTENDED USE: NAME: - . Relaxation of muscle spasms - . Prevention or retardation of disuse atrophy - . Muscle re-education - . post-surgical Immediate stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion . be {1}------------------------------------------------ Description of Device: A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence. Non-Clinical Tests The KS-138 has been tested in accordance with Submitted: applicable standards for medical device electrical electromagnetic compatibility, and safetv. the particular requirements for safety of nerve and muscle stimulators. > Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. > System level testing including waveform testing was performed in combination the KS-138 stimulator. Clinical Tests Submitted: Conclusion: As the product description and tests as above, the new device: KINGLY STAR Powered Muscle Stimulator KS-138 is as safe and effective as, and the function in a manner equivalent to the predicate device: TAI SHENG Powered Muscle Stimulator TS-166. Thus the new device is substantially equivalent to the predicate devices in this aspect. None {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. APR 1 7 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Kingly Star International Technology Co. % Republic of China Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan Republic of China Re: K062453 Trade/Device Name: Kingly Star Powered Muscle Stimulator, KS-138 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: March 20, 2007 Received: April 2, 2007 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 {3}------------------------------------------------ ### Page 2 - Dr. Ke-Min Jen 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. 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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Sincerely yours, Mark N. Molkerson Mark N. Me lkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number: K Device Name: KINGLY STAR INTL. TECHNOLOGY CO., LTD. KINGLY STAR Powered Muscle Stimulator, KS-138 # 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. Prescription Use V (Part 21 CFR 801 Subpart D) 510(k) Number AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General. Restorative, and Netwogical De Page 1 of 1