CONDUCTIVE GEL

K022006 · The Dezac Group · GYB · Sep 13, 2002 · Neurology

Device Facts

• Record ID: K022006
• Device Name: CONDUCTIVE GEL
• Applicant: The Dezac Group
• Product Code: GYB · Neurology
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended Use

The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Device Story

Conductive gel applied to skin under external electrodes; reduces electrical impedance between electrode surface and skin; facilitates conduction of electrical signals for TENS and EMS therapy; gel is washable; used in clinical or home settings; applied by user or clinician; improves electrical contact efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Colored electrolytic gel; electroconductive media; water-soluble; non-sterile; standalone topical application.

Indications for Use

Indicated for use with TENS and EMS devices to reduce skin-to-electrode contact impedance. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Predicate Devices

• Skylark Batch #6060 Conductive Gel (K983964)

Submission Summary (Full Text)

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# 7.0 510(k) Summary

### 1. Sponsor

# SEP 1 3 2002

The Dezac group 54-56 Bath Road Cheltenham Glos. GL53 7HG United Kingdom Registered in England No. 2186341

| Contact Person | Mr Kevin Herbert, Project Engineer | |
|----------------|------------------------------------|--|
| Phone | [phone] | |
| Fax | [phone] | |
| Email | [e-mail] | |

#### 2. Device Name

| Trade Name of Device | Conductive Gel |
|----------------------|--------------------------|
| Common Name | Electrolytic Gel |
| Classification name | Media, Electroconductive |
| Product Code | GYB |
| Regulation Class | Ila |
| Regulation Number | 882.1275 |

#### 3. Indications for Use

The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS The Conductive Gel is used with external electrodes to reduce the (electrical muscle stimulators). impedance of the contact between the electrode surface and the skin.

## 4. Device Description

The Conductive Gel is a colored gel used for reducing the impedance between electrodes and the skin. The gel is to be generously applied to the area under an electrode, which is to be used. The gel can be washed off the skin after use.

## 5. Basis for Substantial Equivalence

#### Predicate Device

Skylark Batch #6060 Conductive Gel

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K983964 Skylark Device Co Ltd. 34 Chung Shan North Road 12th Floor, Sec 3 Taipei, Taiwan

The Conductive Gel is substantially equivalent to Class IIa gels that are also indicated for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). Conductive gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The gel is safe and effective for the conduction of electrical signals for the given indications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 3 2002

The Dezac Group c/o Ms. Wendy Parsley Senior Associate, Regulatory Affairs M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002

Re: K022006

Trade/Device Name: Conductive Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: June 18, 2002 Received: June 19, 2002

Dear Ms. Parsley:

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 - Ms. Wendy Parsley

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.

Stupturber

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Conductive Gel Device Name:

Indications For Use:

The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electronic muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styp Rurd

(Division Sign-Off) Division of General, Restorative and Neurological Devices

(Optional Format 3-10-98)

510(k) Number_________________________________________________________________________________________________________________________________________________________________