ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES

K030800 · Eletromed, Inc. · GXY · Jun 11, 2003 · Neurology

Device Facts

• Record ID: K030800
• Device Name: ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
• Applicant: Eletromed, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed 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) of PGF (Pulsed Galvanic Stimulation). These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a physician.

Device Story

Device consists of reusable cutaneous electrodes serving as conductive adhesive interface between patient skin and electrical stimulators. Inputs: electrical signals from TENS, EMS, IF, or PGF stimulators. Outputs: delivery of electrical stimulation to patient tissue. Used in clinical or home settings under physician order. Benefits: facilitates electrical nerve/muscle stimulation therapy.

Clinical Evidence

No clinical data. Bench testing demonstrated electrical output and characteristics are substantially equivalent to predicate devices.

Technological Characteristics

Cutaneous electrodes; conductive adhesive interface; various form factors (round, oval, rectangular). Biocompatible materials per Tripartite Biocompatibility Guidance.

Indications for Use

Indicated for use as a conductive adhesive interface between patient skin and electrical stimulators (TENS, EMS, IF, or PGF). Restricted to sale by or on the order of a physician.

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

• K963125 (M & R Manufacturing, Inc.)
• K932849 (Pepin Mfg., Inc.)

Submission Summary (Full Text)

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## 'JUN 1 1 2003

# KO 30800

## 11_Appendix_D_510(K)Summary

### 510(k) Summary

| Submitter's Information: | Lydia Baynes<br>Electromed<br>4938 Hampden Lane<br>#750<br>Bethesda, MD 20814 | Phone: [phone]<br>FAX: [phone] |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Date of preparation: | March 11, 2003 | |
| Proprietary Name: | Electromed Reusable Neurostimulation Electrodes | |
| Common Name: | Neurostimulation Electrodes | |
| Classification Name: | Electrodes, cutaneous | |
| Predicate Device: | K963125 (M & R Manufacturing, Inc.)<br>K932849 (Pepin Mfg., Inc.) | |
| Description of Device: | Electrodes, cutaneous | |
| Intended Use: | Electromed Reusable Neurostimulation Electrodes are intended for use as the<br>disposable, conductive adhesive interface between the patient's skin and the<br>Electrical Stimulator. Electromed Reusable Electrodes are designed and<br>intended to be used with marketed, Electrical Stimulators i.e. TENS<br>(Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular<br>Stimulation, IF (Interferential) of PGF (Pulsed Galvanic Stimulation). | |
| Technological Comparison: | The Electromed has technological characteristics that are substantially<br>equivalent to those of the predicate device, as determined criteria specified in the<br>Tripartite Biocompatibility Guidance for Medical Devices. | |
| Labeling Comparison: | The labeling of the Electromed is substantially equivalent to that of the predicate<br>device. | |
| Nonclinical Testing: | Bench testing demonstrated that the characteristics or Electromed are<br>substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The Electromed is substantially equivalent in electrical output to the predicate<br>device and any differences between the devices do not pose new questions of safety. | |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Ms. Lydia Baynes ElectroMed, Inc. 4938 Hampden Lane #750 Bethesda, MD 20814

Re: K030800

Trade/Device Name: ElectroMed Reusable Neurostimulation Electrodes ™ sizes - 32mm round, 54x34mm, 50x90mm, 40x60mm oval, and 50x100mm oval Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrodes Regulatory Class: Class II Product Codes: GXY Dated: March 11, 2003 Received: March 13, 2003

Dear Ms. Baynes

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, 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 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

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Page 2 - Ms. Lydia Baynes:

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. 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), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

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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#### Indications for Use 4

510(k) Number:

Device Name: Electromed Reusable Neurostimulation Electrodes™

030800

Indications for Use:

Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed 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) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Milburn

Division Sign-Off of Ceneral. Restorative nd Neurological Devices

510(k) Number K030820

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