IF-727 INTERFERENTIAL STIMULATOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle with three wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 6 1998 Mr. George K. C. Chen Skylark Device Company Limited Chunq Shan North Road 12th Floor, 34, Section 3 Taipei, Taiwan Re : K974585 Trade Name: IF-727 Interferential Stimulator Requlatory Class: Unclassified Product Code: LIH Dated: November 27, 1997 Received: December 8, 1997 Dear Mr. Chen: We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory -------In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 - Mr. George K. C. Chen This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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/ f Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page_ 1 of 1 510(k) Number (if known): Device Name: IF-727 INTERFERENTIAL STIMULATOR Indications For Use: ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. KEEP OUT OF THE REACH OF CHILDREN. (F_EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF **EEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--------------------------| | <img alt="Signature" src="signature.png"/> | | | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K974585 | | Prescription Use | X | | (Per 21 CFR 801.1091) | | | OR | | | Over-The-Counter Use | ______ | | | (Optional Format 1-2-96) |