Hivox Self Adhesive Electrode Gel Pads
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131720 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hivox Self Adhesive Electrode Gel Pads function as a conductive interface between patient skin and electrical stimulators, including TENS, EMS, and IF devices. These pads are applied to an electrode to facilitate the transmission of electrical signals.
This non-sterile, single-patient-use, disposable device is intended for use in both clinical and home settings by patients or healthcare providers. The product has received FDA 510(k) clearance under K131720.
Frequently asked questions
What is the primary function of these gel pads?
These pads act as a conductive interface between the patient's skin and electrical stimulators. They are applied to an electrode to ensure the effective transmission of electrical signals during TENS, EMS, or IF therapy.
Are these electrode pads intended for multiple patients?
No, these are single-patient-use, disposable devices. They are designed to be used by one individual to maintain hygiene standards and prevent cross-contamination between users.
Are these gel pads sterile?
No, the Hivox Self Adhesive Electrode Gel Pads are supplied as non-sterile devices. They are intended for use in both clinical and home environments as specified by the manufacturer.
What is the regulatory status of this device?
This device has received FDA 510(k) clearance under K131720. This indicates that the product has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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. Sources consulted: HIVOX SELF ADHESIVE ELECTRODE GEL PADS (K131720) - Innolitics, Hivox Biotek Inc., Hivox Self Adhesive Electrode Gel Pads - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131720 | Class II | Active |
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Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- FDA Applicant
- Hivox Biotek, Inc.
Sources (1)
- FDA 510(k) K131720 24 fields · synced Sep 25, 2026