CARE IFC PLUS

{0}------------------------------------------------ # MAY 1 6 2002 K020516 #### 13 Appendix G: 510 (k) Summary ## 510(k) Summary | Submitter's Information: | Christian E. Hunt<br>Care Rehab®<br>1124 Dominion Ct<br>McLean, VA 22102 | Phone: 1-703-448-9644<br>FAX: 1-703-356-2182. | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Date of preparation: | May 14, 2002 | | | Proprietary Name: | CARE IFC plus™ | | | Common Name: | Interferential Stimulator (LIH) | | | Classification Name: | Stimulator Interferential (LIH); Unclassified | | | Device Classification: | Unclassified | | | Predicate Device: | HMP4000 Interferential Stimulator (K924961) | | | Description of Device: | A portable Interferential device for pain control | | | Intended Use: | Interferential treatment is used for symptomatic relief of chronic<br>intractable pain and/or as an adjunctive treatment in the management of<br>postsurgical and posttraumatic acute pain. | | | Technological Comparison: | The CARE IFC plus™ has technological characteristics that are<br>substantially equivalent to those of the predicate device, as determined<br>by bench testing. | | | Labeling Comparison: | The labeling of the CARE IFC plus™ is substantially equivalent to that<br>of the predicate device. | | | Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE<br>IFC plus™ are substantially equivalent to that of the predicate device. | | | Clinical Testing: | Not applicable. | | | Conclusions from Testing: | The CARE IFC plus™ is substantially equivalent in electrical output to<br>the predicate device and any differences between the devices do not pose<br>new questions of safety and effectiveness. | | ર I {1}------------------------------------------------ Image /page/1/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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is rendered in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 6 2002 Mr. Christian E. Hunt Care Rehab 1124 Dominion Ct. McLean, VA 22102 Re: K020516 Trade/Device Name: CARE IFC plus Regulatory Class: Unclassified Product Code: LIH Dated: February 14, 2002 Received: February 15, 2002 Dear Mr. Hunt: 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. 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. {2}------------------------------------------------ ### Page 2 - Mr. Christian Hunt If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html Sincerely yours, Miriam C. Provost O 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 {3}------------------------------------------------ ### 4 Indications for Use 510(k) Number: Device Name: CARE IFC plus™ Indications for Use: Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K0205/6 6