← Product Code [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF) · K965065 # TECA. MILLENNIUM (K965065) _Medelec , Ltd. · GWF · Jun 20, 1997 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K965065 ## Device Facts - **Applicant:** Medelec , Ltd. - **Product Code:** [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF.md) - **Decision Date:** Jun 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1870 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The Millennium is a 2 or 5 channel electromyograph which provides facilities for RMG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner. ## Device Story Millennium is a 2 or 5 channel electromyograph (EMG) system; records, displays, and documents electrophysiological signals from human nervous and muscular systems. Used in clinical environments by physicians or licensed practitioners for EMG and evoked potentials testing. Device transforms raw electrical signals into visual waveforms for clinician review; aids in diagnostic assessment of neuromuscular function. Benefits include reliable data acquisition for clinical decision-making. ## Technological Characteristics 2 or 5 channel electromyograph; supports EMG and evoked potentials testing; clinical environment use. ## Regulatory Identification An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response. ## 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 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 20 1997 Mr. Jeff Hall Quality Assurance Manager Medelec Limited Manor Way Old Woking Surrey GU22 9JU UNITED KINGDOM Re: K965065 Trade Name: Millenium Regulatory Class: II Product Code: 84GWF, 84GWE, 84GWJ, 84JXE, and 89IKN Dated: March 26, 1997 Received: March 31, 1997 Dear Mr. Hall: 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any {1} Page 2 - Mr. Jeff Hall 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. 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) 594-4648. 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" (21 CFR 807.97). 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/dsmamain.html". Sincerely yours, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page of 510(k) Number (if known): K965065 Device Name: MILLENNIUM Indications For Use: The indications for use statements shown below are now to be included in the Millennium User Manual, see Introduction Section under the headings of System Overview and Cautions and Warnings respectively. The Millennium is a 2 or 5 channel electromyograph which provides facilities for RMG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) 01/01'd AIO TNIOM SHXOIA 020/91 58410 12:91 1661-60-20 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K965065](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K965065) **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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