THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

K020445 · The Electrode Store, Inc. · GXY · May 10, 2002 · Neurology

Device Facts

• Record ID: K020445
• Device Name: THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
• Applicant: The Electrode Store, Inc.
• Product Code: GXY · Neurology
• Decision Date: May 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for non-invasive use as recording or stimulating electrodes during electromyography (EMG), nerve conduction studies (NCS), and evoked potential (EP) recordings in patients undergoing these diagnostic procedures.

Regulatory Classification

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)

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Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR §801.109)

Over-The-Counter Use_

Indications for Use Statement