Identifiers
- 510(k) Number
- K962681 FDA 510(k)
- FDA Product Code
- GYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1275 FDA 510(k)
- Regulation Number
- 882.1275 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ECOGEL 300 TENS GEL is a media, electroconductive device used in neurology applications. It is designed to facilitate the transmission of electrical signals from transcutaneous electrical nerve stimulation (TENS) units to the skin.
The device is supplied as a conductive gel for use with TENS equipment in clinical or home settings. It is not sterile, not MRI safety information is provided, and no details on single-use or reusable status, sizes, storage conditions, or additional authorisations beyond FDA 510(k) clearance (K962681) are specified in the data.
Frequently asked questions
What is the ECOGEL 300 TENS GEL used for?
The ECOGEL 300 TENS GEL is used to facilitate the transmission of electrical signals from transcutaneous electrical nerve stimulation (TENS) units to the skin, specifically in neurology applications, to support nerve stimulation therapy in clinical or home environments.
Is the ECOGEL 300 TENS GEL sterile?
The ECOGEL 300 TENS GEL is not sterile, as explicitly stated in the device data, which means it should not be used in sterile procedures and must be handled according to standard non-sterile gel protocols for TENS applications.
What regulatory authorization does the ECOGEL 300 TENS GEL have?
The ECOGEL 300 TENS GEL has FDA 510(k) clearance under K962681, indicating it was found substantially equivalent to a legally marketed predicate device, based on the traditional review pathway for a neurology-classified electroconductive media device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962681 | Class II | Active |
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Manufacturer
- Manufacturer
- Eco-Med Pharmaceuticals, Inc.
Sources (1)
- FDA 510(k) K962681 24 fields · synced Sep 21, 2026