(33 days)
Not Found
Not Found
No
The summary describes a conductive gel, which is a passive material and does not incorporate AI/ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a conductive gel used with TENS and EMS devices, not a therapeutic device itself. It facilitates the function of therapeutic devices but doesn't provide therapy on its own.
No
The device is a conductive gel used with TENS and EMS devices to improve electrode contact with the skin, not to diagnose a condition.
No
The device description clearly states "BATCH #6060 CONDUCTIVE GEL," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with TENS and EMS devices to improve electrical conductivity between electrodes and the skin. This is a physical interaction, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: It's described as "CONDUCTIVE GEL," which aligns with its intended use for electrical conductivity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IKC
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1275 Electroconductive media.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| --------------------------- | ---------- |
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