INF 4160, MODEL D-FJ27F

{0}------------------------------------------------ ## FEB 1 1 2005 10 510(k) Summary This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is:_ K043407 #### 10.1 Submitter's Identification Fuji Dynamics Ltd. Unit 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road, Kowloon, Hong Kong Tel: (852) 2786 4218 Fax: (852) 2744 6775 Anthony Ah Yin, Shum Contact Person: December 6th 2004 Date Prepared: | 10.2 Name of Device: | | |------------------------|---------------------------| | Proprietary Name: | INF 4160 | | Model Number: | D-FJ27F | | Common or Usual Name: | Interferential Stimulator | | Product Code: | LIH | | Device Classification: | unclassified | ## 10.3 Predicate Device Information: The INF 4160 is equivalent to the IF-4000 (510(k) No .: K952683). #### 10.4 Device Description: The INF 4160 is a rechargeable battery operated Interferential Current Therapy Device. Its internal circuitry can generate symmetrical sinusoidal waveforms. The associated outputs are delivered through lead cables to electrodes placed on the user/patient skin. The output passes through the skin and activates the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation. {1}------------------------------------------------ ## 10.5 Intended Use: The intended uses of the INF 4160 are: - Symptomatic relief of chronic intractable pain . - Adjunctive treatment for the management of post-traumatic or ● post-surgical pain. ## 10.6 Technological Comparison to Predicate Device: The INF 4160 has basic technological characteristics that are substantially equivalent to the predicate device. The major significant technological difference between the two devices is that INF 4160 uses a pack of rechargeable batteries as the power source. The INF 4160 will cutoff the power source if the battery voltage drops below a preset value. In addition, it cannot be operated while the batteries are recharging. Therefore, this difference will not affect the safety and effectiveness of the device. Both units use "shrouded patient cable connectors" to comply with the FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables." ## 10.7 Non-clinical Testing: Compliance to applicable voluntary standards includes ANSI/AAMI NS4-1986 items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2, as well as EN 60601-1-2 requirements. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance. ### 10.8 Clinical Testing Not Applicable as there are no new or innovative aspects that have been introduced. ## 10.9 Conclusions: The INF 4160 has the same intended use and similar technical characteristics as the IF-4000 (510(k) No.: K952683). The information supplied in this 510(k) illustrates that the device do not pose any new questions of safety and effectiveness. Therefore, the INF4160 is substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three curved lines that resemble a bird in flight. The logo is presented in black and white. Public Health Service FEB 1 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Anthony Shum R&D Manager Fuji Dynamics Ltd. Liyatong Industrial District Lin Chun, Tang Xia Dong Guan, Guangdong, China Re: K043407 Trade/Device Name: INF 4160 Regulation Number: Unclassified Regulatory Class: Interferential Current Therapy Device Product Code: LIH Dated: January 18, 2005 Received: January 18, 2005 Dear Mr. Shum: 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 - Mr. Shum This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will and w your he FDA finding of substantial equivalence of your device to a legally premative nedicate 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 it you active 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 other general milermational 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/industry/support/index.html. Sincerely yours, L. Mark A. Milkanon 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 {4}------------------------------------------------ QUESTION 8 # Appendix A-Indication For Use 510(k) Number (if known): K043407 Device Name: INF 4160 Indications For Use: The INF 4160 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. AND/OR Prescription Use X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODF) Mark A Milkers (Division Sign-Off) Division of General, Restorative, Neurological Devices 510(k) Number K043407 Page 1 of 1