STIMPOD NMS460 Nerve Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161091 FDA 510(k)
- FDA Product Code
- GZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STIMPOD NMS460 Nerve Stimulator is a medical device classified as a nerve stimulator, designed to deliver controlled electrical stimulation to nerves for diagnostic or therapeutic purposes. It is intended for use in neurological assessments, helping to evaluate nerve function, identify nerve conduction issues, or assist in procedural guidance during interventions such as nerve blocks or pain management therapies.
This device is supplied as a reusable medical instrument and is regulated under both FDA 510K clearance and MDR authorisation. It is intended for use in clinical settings, including hospitals and specialised neurological practice environments, and must be handled according to sterile or aseptic techniques when applicable. The STIMPOD NMS460 is available in a single model configuration, adhering to safety standards for electrical medical devices and requiring proper storage to maintain functionality and compliance with regulatory requirements.
Frequently asked questions
Is the STIMPOD NMS460 nerve stimulator intended for single-use or can it be reused in clinical settings?
The STIMPOD NMS460 is explicitly described as a reusable medical instrument. Since it is used in clinical settings like hospitals and neurological practices, proper cleaning, maintenance, and adherence to sterile or aseptic techniques must be followed to ensure safe reuse. Reusability is also consistent with its regulatory classification as a reusable device under both FDA 510(k) and MDR frameworks.
What clinical environments is the STIMPOD NMS460 nerve stimulator primarily intended for, and how does that affect its use?
The STIMPOD NMS460 is designed for use in clinical settings such as hospitals and specialized neurological practice environments. Its application involves neurological assessments, nerve conduction evaluations, or procedural guidance (e.g., nerve blocks or pain management). Because it operates in regulated clinical spaces, it must comply with sterile or aseptic handling protocols when applicable, ensuring patient safety and device integrity during diagnostic or therapeutic procedures.
How many models of the STIMPOD NMS460 nerve stimulator are available, and what factors should be considered when selecting it for a procedure?
The STIMPOD NMS460 is available in a single model configuration, meaning there are no variations in size or functionality to choose from. When selecting this device, clinicians should consider its controlled electrical stimulation capability for nerve assessments or procedural guidance, ensuring it aligns with the specific diagnostic or therapeutic needs of the patient. Compatibility with sterile techniques and adherence to regulatory storage requirements are also critical factors.
What regulatory pathways does the STIMPOD NMS460 nerve stimulator follow, and how does this impact its use in different markets?
The STIMPOD NMS460 is regulated under both FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, indicating it has undergone evaluations for safety and performance in the U.S. and EU markets, respectively. This dual authorization ensures compliance with stringent electrical medical device standards, allowing its use in clinical settings where such regulatory approvals are required. Buyers should confirm local regulatory compliance before deployment, as these pathways may influence market availability and usage guidelines.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161091 | Class II | Active |
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Manufacturer
- Manufacturer
- Xavant Technology (pty) Ltd
- FDA Applicant
- Xavant Technology (Pty), Ltd.
Sources (2)
- FDA 510(k) K161091 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026