BATCH #6060 CONDUCTIVE GEL

K983964 · Skylark Device Co., Ltd. · GYB · Dec 9, 1998 · Neurology

Device Facts

• Record ID: K983964
• Device Name: BATCH #6060 CONDUCTIVE GEL
• Applicant: Skylark Device Co., Ltd.
• Product Code: GYB · Neurology
• Decision Date: Dec 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.

Device Story

Conductive gel applied to skin surface; functions as interface medium between external electrodes and patient skin; reduces electrical impedance to facilitate transmission of TENS or EMS signals. Used in clinical or home settings by patients or healthcare providers. Benefits include improved electrical contact and signal efficiency for nerve/muscle stimulation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Conductive gel formulation; non-sterile; designed for topical application to reduce skin-electrode impedance. No specific material standards or software components described.

Indications for Use

Indicated for use with TENS and EMS devices to reduce impedance between electrode surface and skin for patients requiring electrical nerve or muscle stimulation.

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.

Submission Summary (Full Text)

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DEC 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. George K.C. Chen President and CEO Skylark Device Company Limited 12th Floor, 34 Section 3 Chung Shan North Road Taipei Taiwan ROC

Re: K983964 Batch #6060 Conductive Gel Trade Name: Regulatory Class: II Product Code: IKC Dated: November 2, 1998 Received: November 6, 1998

Dear Mr. Chen:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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.

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## Page 2 - Mr. George K.C. Chen

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 requlation (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/ccrh/dsmamain.html".

Sincerely yours,

Colin M. Witton, Ph. D., M.

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

Enclosure

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| 510(k) Number (if known): | K98 3964 |
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BATCH #6060 CONDUCTIVE GELsvice Name:

Indications For Use:

FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE 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)

Division Sign Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983964

Over-The-Counter Use

Prescription Use `er 21 CFR 801.109) OR