(86 days)
Not Found
No
The 510(k) summary describes a conductive gel, a passive material, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a conductive gel used with therapeutic devices (TENS and EMS), but it is not a therapeutic device itself. Its function is to reduce impedance for better contact between electrodes and the skin, rather than to deliver therapy directly.
No
The device, Conductive Gel, is intended for use with TENS and EMS devices to reduce impedance and facilitate electrical current transmission. It does not perform any diagnostic function itself.
No
The device description clearly states it is a "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 is to reduce impedance between electrodes and the skin for TENS and EMS devices. This is a physical interaction with the body's surface to facilitate electrical conductivity.
- Device Description: The description reinforces the physical nature of the gel's function.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening of diseases.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This conductive gel does not fit that definition.
N/A
Intended Use / Indications for 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.
Product codes
GYB
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.
Mentions image processing
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
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 | +44 1242 702300 | |
| Fax | +44 1242 702301 | |
| kherbert@dezac.co.uk |
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
1
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.
2
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.
3
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 (301) 594-4639. 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" (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 (800) 638-2041 or (301) 443-6597 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
4
| Page | of |
|---|---|
| ------ | ---- |
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_________________________________________________________________________________________________________________________________________________________________