EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020

K983741 · Axelgaard Mfg. Co., Ltd. · GXY · Dec 18, 1998 · Neurology

Device Facts

• Record ID: K983741
• Device Name: EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
• Applicant: Axelgaard Mfg. Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

Device Story

Everlast Neurostimulation Electrodes are conductive pads used with transcutaneous neurostimulation devices. They interface between the stimulator and the patient's skin to deliver electrical pulses. Used in clinical or home settings under physician guidance or prescription. The electrodes facilitate the transmission of therapeutic electrical signals to nerves for pain management or muscle stimulation. They are disposable, patient-applied components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Conductive neurostimulation electrodes; form factor designed for transcutaneous application; materials and construction consistent with standard neurostimulation electrode specifications.

Indications for Use

Indicated for use with transcutaneous neurostimulation devices for patients requiring neurostimulation therapy.

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

Image /page/0/Picture/2 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

DEC 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan P. Jeffery President Axelgaard Manufacturing Company, Limited 1667 South Mission Road Fallbrook, California 92028-4115

Re: K983741 Everlast Neurostimulation Electrodes Trade Name: Regulatory Class: II Product Code: GXY Dated: October 21, 1998 October 22, 1998 Received:

Dear Mr. Jeffery:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.

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## Page 2 - Mr. Dan P. Jeffery

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 [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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to co.erda

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment I b

Page of

510(k) Number (if known):___ K 983741

Device Name: Everlast Neurostimulation Electrodes

Indications For Use:

The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-On)
Division of General Restorative Devices
510(k) Number. K983741

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)