← Product Code [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ) · K021496 # HMS-DHR-3 NEUROMUSCULAR STIMULATOR (K021496) _Home Medical Services · GZJ · Aug 6, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K021496 ## Device Facts - **Applicant:** Home Medical Services - **Product Code:** [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ.md) - **Decision Date:** Aug 6, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5890 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN ## Device Story HMS-DHR-3 Neuromuscular Stimulator; transcutaneous electrical nerve stimulator (TENS) for pain management. Device delivers electrical impulses to nerves to provide symptomatic relief of chronic intractable pain. Used by patients for pain relief; operation involves application of electrodes to skin. Output affects sensory nerve pathways to modulate pain perception. Benefits include non-invasive management of chronic pain conditions. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and intended use consistent with existing Class II TENS devices. ## Technological Characteristics Transcutaneous electrical nerve stimulator (TENS); Class II device (21 CFR 882.5890); electrical output for nerve stimulation. ## Regulatory Identification A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## AUG 0 6 2002 C. A. Teklinski Home Medical Services 9393 Activity Road, Suite F San Diego, California 92126 Re: K021496 > Trade/Device Name: HMS-DHR-3 Neuromuscular Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: May 6, 2002 Received: May 9, 2002 Dear Mr. Teklinski: 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 {1}------------------------------------------------ Page 2 - C. A. Teklinski 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. 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) 594-4648. 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, Mark N. Milkenner 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 {2}------------------------------------------------ ## HMS NEUROMUSCULAR STIMULATOR (021496 (510 (k) #_ ## INDICATIONS FOR USE THE INDICATION FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT IS AS FOLLOWS : SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN Mark N. Millhuser (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _ --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K021496](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K021496) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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