EZ-STIK ELECTRODES

K050469 · Naimco, Inc. · GXY · May 13, 2005 · Neurology

Device Facts

• Record ID: K050469
• Device Name: EZ-STIK ELECTRODES
• Applicant: Naimco, Inc.
• Product Code: GXY · Neurology
• Decision Date: May 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NAImco, Inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAImco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Device Story

EZ-stik Electrodes function as a conductive adhesive interface between patient skin and electrical stimulators; used with TENS, EMS, IF, or PGF devices. Device consists of conductive components (Amgel 703 or 702 and conductive plastic film) to facilitate electrical signal transfer from stimulator to patient. Intended for clinical or home use as a disposable accessory. No active processing or software components involved.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Cutaneous electrode; materials include Amgel 703 or 702 and conductive plastic film. Passive conductive interface; no energy source or software.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and electrical stimulators (TENS, EMS, IF, or PGF) for patients requiring electrical stimulation 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.

Predicate Devices

• Selective Med Components (K945676)
• Axelgaard Manufacturing (K970426)
• Everyway Medical (K012463)

Submission Summary (Full Text)

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K050469

MAY 1 8 2005

## www.naimco.com

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Plant: 888-549-4945 Fax: [phone]

## 510(k) Summary

| Submitter's Information: | Robert L. McClure, Jr., FAIC<br>NAlmco, Inc.<br>4120 South Creek Road<br>Chattanooga, TN 37406 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | February 21, 2005 |
| Proprietary Name: | EZ-stik Electrodes |
| Common Name: | Neurostimulation Electrodes |
| Classification Name: | Electrodes, Cutaneous |

| Phone: | 888-549-4945 |
|--------|--------------|
| Fax: | 423-648-7735 |

| Predicate Device: | K945676 (Selective Med Components)<br>K970426 (Axelgaard Manufacturing)<br>K012463 (Everyway Medical) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Device: | Electrodes, Cutaneous |
| Intended Use: | The NAImco, Inc. EZ-stik electrodes are intended for use as a<br>disposable, conductive adhesive interface between the<br>patient's skin and the Electrical Stimulator. NAImco's reusable<br>electrodes are designed and intended to be used with<br>marketed, Electrical Stimulators, i.e. TENS (Transcutaneous<br>Electrical Nerve Stimulation), EMS (Electrical Muscular<br>Stimulation), IF (Interferential) or PGF (Pulsed Galvanic<br>Stimulation). |
| Technological Comparison: | The NAImco, Inc. EZ-stik electrodes exhibit technological<br>characteristics that are substantially equivalent to those of the<br>predicate device, as determined by both component usage and<br>physical testing. |
| Labeling Comparison: | The labeling of NAImco, Inc. EZ-stik electrodes is substantially<br>equivalent to those of predicate device. |

Image /page/0/Picture/6 description: The image shows a logo for North American Industrial manufacturing company. The logo features the letters 'NA' stacked on top of each other, with the letters 'mco' to the right. Above the letters 'NA' is a black circle. The text 'North American Industrial manufacturing company' is written below the letters 'NA'.

4120 South Creek Road
Chattanooga, TN 37406

A

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K050469

| | K050469 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Testing: | The (critical) components used in NAlmco, Inc. EZ-stik<br>electrodes (Amgel 703 or Amgel 702 and Conductive Plastic<br>Film) are the same as used in the predicate device. Therefore<br>there is no reason to believe that the NAlmco, Inc. EZ-stik<br>electrodes will perform any different than the predicate device. |
| Clinical Testing: | Not Applicable |
| Conclusions: | The NAlmco, Inc. EZ-stik electrodes are substantially<br>equivalent to those of predicate device and any difference<br>between the devices do not pose new questions of safety and<br>effectiveness. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines forming its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2005

Mr. Robert L. McClure Naimco, Inc. 4120 South Creek Road Chattanooga, Tennessee 37406

Re: K050469

Trade/Device Name: EZ-Stik Electrodes Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: May 2, 2005 Received: May 6, 2005

Dear Mr. McClure:

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 for use stared in the 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, de nees mat have been revat 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 read haly and 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 (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to basil as a sateral 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 r rouse be actived 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 or uny I 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 OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quint on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Robert L. McClure

This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle will anow you to organ miling of substantial equivalence of your device to a legally premarket notification: "The Pro 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), please If you desire specific adrive 101-your as [phone] . Also, please note the regulation entitled, Comace the Office of Companiet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rlurch

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K0S0469

Device Name:

EZ-Stik Electrodes

Indications For Use:

The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OND)

taty Rlurlu
Division Sign-Off)

**Division of General, Restorative,**
**and Neurological Devices**

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510(k) Number: K050464