SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202

{0}------------------------------------------------ K071093 ## 5. SUMMARY OF SAFETY AND EFFECTIVENESS ( According to 21 CFR 807.92) DEC 0 6 2007 DATE OF April 12, 2007 SUBMISSION: SUBMITTER: President, Chin Lin Huang SAN SHIH Electrical Enterprise Co., Ltd. No. 209, Sec. 3, County Boulevard, Pan Chiao City, 22050, Taiwan Hsien, ROC TEL: 886-2-2253-5336 FAX: 886-2-2253-0442 ESTABLISHMENT OWNER NO: d096360 OFFICIAL Dr. JEN, KE-MIN CONTACT: ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY No. 58, Fu-Chiun Street. Hsin Chu City, 30067, Taiwan, ROC TEL: 886-3-5208829 FAX: 886-3-5209783 E-mail: ceirs.jen@msa.hinet.net TRADE NAME: SAN SHIH Powered Muscle Stimulator, 202 COMMON/USUAL Electrical Muscle Stimulator NAME: CLASSIFICATION Powered Muscle Stimulator NAME: REGULATION NUMBER: 890.5850 PREDICATED DEVICE: INTENDED USE: HOME CARE Powered Muscle Stimulator, K023000 - . 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 . {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 202 has been tested in accordance with Submitted: applicable standards for medical device electrical safety, electromagnetic compatibility, and 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 202 stimulator. ## Clinical Tests Submitted: None Conclusion: As the product description and tests as above, the new device: SAN SHIH Powered Muscle Stimulator 202 is as safe and effective as, and the function in a manner equivalent to the predicate device: HOME CARE Powered Muscle Stimulator, K023000. Thus the new device is substantially equivalent to the predicate devices in this aspect. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design. DEC 0 6 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SAN SHIH Electrical Enterprise Co., Ltd % ROC Chinese-European Industrial Research Society Dr. Jen, Ke-Min No. 58, Fu-Chiun Street Hsin Chu City, 30067, Taiwan, ROC Re: K071093 Trade/Device Name: SAN SHIH Powered Muscle Stimulator, 202 Regulation Number: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: October 31, 2007 Received: November 20, 2007 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 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. {3}------------------------------------------------ ## Page 2 - Dr. Jen, Ke-Min 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N Mullens Mark N. Melkerson 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: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Device Name: SAN SHIH Electrical Enterprise Co., Ltd. SAN SHIH Powered Muscle Stimulator, 202 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) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) M Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ceneral Restorative, and Neurological Devices 510(k) Number K071093 Page 1 of 1