Identifiers
- 510(k) Number
- K121816 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 Sensus Electrode is a disposable, conductive adhesive interface classified as a neuromuscular electrical stimulation electrode (Product Code: GXY). It delivers transcutaneous electrical nerve stimulation (TENS) to the skin for pain management, targeting peripheral nerve pathways to alleviate chronic pain symptoms.
This single-use electrode is supplied sterile and designed for attachment to the Sensus Pain Management System, a wearable device for outpatient or home use. It adheres directly to the patient’s skin and is intended for one-time use per manufacturer specifications. The device is cleared under FDA 510(k) (K121816) and falls under the Neurology Advisory Committee’s review category.
Frequently asked questions
What is the Sensus Electrode used for in clinical practice?
The Sensus Electrode is designed as a disposable, conductive adhesive interface for delivering transcutaneous electrical nerve stimulation (TENS) to manage chronic pain. It works by stimulating peripheral nerve pathways through the skin, helping alleviate pain symptoms in outpatient or home settings as part of the Sensus Pain Management System.
Is the Sensus Electrode reusable or intended for single-use?
The Sensus Electrode is explicitly manufactured for single-use only, as stated by the manufacturer. It is supplied sterile and should not be reused after one application to ensure safety and effectiveness.
How is the Sensus Electrode supplied, and what does 'sterile' mean in this context?
The Sensus Electrode is supplied sterile, meaning it undergoes processing to eliminate harmful microorganisms before packaging. This ensures it is safe for direct skin attachment without additional sterilization by the user, as it is intended for one-time use.
What regulatory pathway was followed for FDA clearance of the Sensus Electrode?
The Sensus Electrode was cleared through the FDA 510(k) process (K121816) under the Traditional Review pathway, determined to be *substantially equivalent* to a legally marketed predicate device. It falls under Product Code GXY (neuromuscular electrical stimulation electrodes) and was reviewed by the Neurology Advisory Committee (NE).
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: NEUROMETRIX SENSUS USER MANUAL Pdf Download | ManualsLib, Neurometrix Sensus Manuals | ManualsLib, NeuroMetrix SENSUS - User manual, SENSUS ELECTRODE (K121816) — FDA 510 (k) | Innolitics, NeuroMetrix SENSUS User Manual | AI Chat & PDF Access | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121816 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA 510(k) K121816 24 fields · synced Sep 19, 2026