← Product Code [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY) · K020445 # THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG (K020445) _The Electrode Store, Inc. · GXY · May 10, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K020445 ## Device Facts - **Applicant:** The Electrode Store, Inc. - **Product Code:** [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY.md) - **Decision Date:** May 10, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1320 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. ## Device Story The Electrode Store™ Surface (Cutaneous) Electrode is a passive medical device used for electromyography (EMG), nerve conduction studies (NCS), and evoked potential (EP) recordings. The device functions as an interface between the patient's skin and diagnostic equipment, serving as either a recording (active/reference) or stimulating electrode. It is intended for non-invasive use in clinical settings by healthcare professionals. The device captures electrical signals from the body or delivers electrical stimulation to the body to facilitate diagnostic testing. It does not contain active electronic components, software, or algorithms. ## Clinical Evidence Bench testing only. ## Technological Characteristics Cutaneous electrode for EMG/NCS/EP. Passive device; no energy source, software, or algorithms. Form factor designed for surface application to skin. Sterilization status not specified; materials are standard for cutaneous electrodes. ## Regulatory Identification A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. ## 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 Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other and are rendered in a simple, flowing line style. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 The Electrode Store c/o Carl Youngmann, Ph.D., RAC R.A. Associates 936-11th Avenue East Seattle, WA 98102 Re: K020445 Trade/Device Name: The Electrode Store™ Surface (Cutaneous) Electrode for EMG Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: February 8, 2002 Received: February 11, 2002 Dear Dr. Youngmann: 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. Iisting 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. {1}------------------------------------------------ ## Page 2 – Carl Youngmann, Ph.D., RAC 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) 594-4659. 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, Muriam C. Provost Ja 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}------------------------------------------------ THE ELECTRODE STORE™ Surface (Cutaneous) Electrode 510(k) Indications for Use Statement 510(k) Number: K 020445 The Electrode Store™ Surface (Cutaneous) Electrode for EMG Device Name: Indications for Use: The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. Musician C. Provost ivision Sign-Off) Division of General, Restorative and Neurological Devices **510(k) Number** K020445 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ાર Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR §801.109) Over-The-Counter Use_ Indications for Use Statement --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K020445](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K020445) **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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