FlexStim Neurostimulation Electrodes (Numbers: 5050ROC1S +7 more)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161282 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 FlexStim Neurostimulation Electrodes are reusable, adhesive electrodes designed for transcutaneous electrical nerve stimulation (TENS) and neurostimulation applications. These electrodes facilitate neuromodulation by delivering electrical impulses to targeted nerve pathways, aiding in pain management and neuromuscular stimulation therapies.
Supplied sterile or non-sterile as indicated by the model suffix (S for sterile, W for non-sterile), these electrodes are intended for single-use or reusable applications depending on clinical protocols. They are compatible with MRI environments and come in various configurations (ROC and SQC) with single (1) or dual (2) channel options. Authorised under FDA 510K, MDD, and MDR, the devices are regulated for medical use in neurostimulation procedures.
Frequently asked questions
Are these electrodes safe to use during an MRI scan, and how does that affect their selection?
Yes, the FlexStim Neurostimulation Electrodes are explicitly designed to be MRI-compatible, making them suitable for use in MRI environments. This feature is particularly important for patients who require both neurostimulation therapy and MRI imaging without the risk of interference or safety hazards. When selecting models, ensure compatibility aligns with your clinical workflow, as all listed models (5050ROC1S, 5050ROC1W, etc.) support MRI-safe applications.
How do I determine whether I should purchase the sterile (S) or non-sterile (W) version of these electrodes?
The sterile (S) and non-sterile (W) versions are differentiated by their intended use in clinical settings. The sterile models (e.g., 5050ROC1S) are intended for procedures where aseptic conditions are required, such as invasive or high-risk applications. The non-sterile models (e.g., 5050ROC1W) are suitable for routine or non-invasive neurostimulation therapies where sterility is not a primary concern. Choose based on your facility’s infection control protocols and the specific clinical procedure.
Can these electrodes be reused, and if so, what factors should I consider before deciding?
The FlexStim Neurostimulation Electrodes are designed for both single-use and reusable applications, depending on clinical protocols. Reusability is determined by your facility’s policies, patient care standards, and the condition of the electrodes after use. Factors to consider include adherence to cleaning protocols (if reused), potential skin sensitivity or irritation, and the risk of contamination. Always follow your institution’s guidelines for electrode reuse to ensure patient safety and device efficacy.
What are the key differences between the ROC and SQC configurations, and how do they impact clinical use?
The ROC and SQC configurations refer to the electrode layout and channel compatibility for neurostimulation. ROC models (e.g., 5050ROC1S) are designed for single or dual-channel applications with a specific adhesive pattern suited for targeted nerve stimulation. SQC models (e.g., 5050SQC2S) feature a square configuration, which may offer broader coverage or alternative placement options depending on the anatomical area being treated. The choice between them depends on the therapy protocol, patient anatomy, and whether single or dual-channel stimulation is required.
What regulatory pathways have these electrodes undergone, and how does that affect their adoption in clinical settings?
The FlexStim Neurostimulation Electrodes have been authorized through FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) pathways, confirming their compliance with stringent safety and performance standards in the U.S., EU, and other regulated markets. This regulatory backing ensures they meet established guidelines for neurostimulation devices, providing clinicians and facilities with confidence in their use for pain management and neuromuscular therapies. Always verify local regulatory requirements before adoption.
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 (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161282 | Class II | Active |
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Manufacturer
- Manufacturer
- Medico Electrodes International Ltd.
- FDA Applicant
- Medico Electrodes International , Ltd.
Sources (2)
- FDA 510(k) K161282 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026