EMG RECORDING RING ELECTRODE

K953356 · Chalgren Enterprises, Inc. · GXY · Jan 22, 1996 · Neurology

Device Facts

• Record ID: K953356
• Device Name: EMG RECORDING RING ELECTRODE
• Applicant: Chalgren Enterprises, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Device Story

The EMG Recording Ring Electrode is a device used for the acquisition of electromyographic (EMG) signals. It functions as an interface between the patient's skin and an EMG recording system. The device is intended for use by clinicians or technicians in a clinical setting to facilitate the monitoring or diagnostic recording of muscle electrical activity. The electrode captures electrical signals from the skin surface, which are then transmitted to an external EMG machine for processing and display. This allows healthcare providers to assess muscle function and diagnose neuromuscular conditions. The device is a passive component in the signal acquisition chain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surface electrode for EMG signal acquisition. Passive electrical component. Form factor: ring electrode. Materials and specifications not detailed in the provided text.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JAN 22 1996

Richard Kaiser, CEO
Chalgren Enterprises, Inc.
8021 Carmel Street
Gilroy, California 95020

Re: K953356
EMG Recording Ring Electrode
Regulatory Cass: II (two)
Product Code: 84 GXY
Dated: October 16, 1995
Received: October 23, 1995

Dear Mr. Kaiser:

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 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 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 immediately allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at [phone]. Other general information

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I am responsible for all the facts and circumstances under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D.
Acting Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health