FINESUN EMS STIMULATOR

{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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 1 2008 Finesun Worldwide Int'l Co., Ltd. % Chi-Chu Wu Chen New Century Technology 3F, No. 31, Hu-Pin Road #1 Hsin-Chu, Taiwan Re: K020684 Trade/Device Name: Finesun EMS Stimulator, Models FS-004, FS-008, FS-012, FS-016 and FS-020 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 27, 2002 Received: March 4, 2002 Dear Mr. Chen: This letter corrects our substantially equivalent letter of May 23, 2002. 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 for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered prox to 110 - 110 - 120 - 120 - 12 - 12 - 11 - 11 - 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 r ou may attress, and include requirements for annual registration, listing of general controls provision 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 ir your device to such additional controls. Existing major regulations affecting your device can may be subject to back as one as a may be marts 800 to 898. In addition, FDA may be round in ther over ents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actives and I Drivision that your device complies with other requirements of the Act that 1 Dr Has Intactions and regulations administered by other Federal agencies. You must or any I edelar status and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 007); idocime (21 CFR Part 820); and if applicable, the electronic form in the quany by overs of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 -- Chi-Chu Wu Chen This letter will allow you to continue 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 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, Mark N. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 3.0 INDICATIONS FOR USE STATEMENT 510(k) Number (if know) Finesun EMS Stimulator Device Name Indications for Use: For model FS-004 - Relaxation of muscle spasms ● For models FS-008, FS-012, FS-016 and FS-020 - Relaxation of muscle spasms . - Prevention or retardation of disuse atrophy . - Increasing local blood circulation ● - Muscle re-education ● - Immediate post-surgical stimulation of calf muscles . to prevent venous thrombosis - Maintaining or increasing range of motion . PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) or Prescription Use (Per 21 CFR 801.109) Over -The-Counter Use_ for Mark N. Milken (Division Sign Off) ion of General, Restorative Neurological Devices 510(k) Number K020684