StimPod NMS450 Nerve Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102084 FDA 510(k)
- FDA Product Code
- BXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2775 FDA 510(k)
- Regulation Number
- 868.2775 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The StimPod NMS450 Nerve Stimulator is a battery-powered device designed for nerve stimulation. Classified as a nerve stimulator under the nomenclature authority, it is intended for use in anesthesiology procedures to facilitate nerve localization and block confirmation during regional anesthesia applications.
This device is supplied sterile and is intended for single-use. It is regulated under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), with FDA clearance via a 510(k) submission (K102084). The StimPod NMS450 is MRI-unsafe and must be stored in its original packaging to maintain sterility. It is distributed globally under product code BXN.
Frequently asked questions
What is the primary purpose of the StimPod NMS450 Nerve Stimulator?
The StimPod NMS450 Nerve Stimulator is designed for nerve stimulation and is intended for use in anesthesiology procedures to facilitate nerve localization and block confirmation during regional anesthesia applications.
Is the StimPod NMS450 Nerve Stimulator reusable or single-use?
The StimPod NMS450 Nerve Stimulator is supplied sterile and is intended for single-use only. It must be discarded after a single procedure to maintain safety and sterility.
What are the storage requirements for the StimPod NMS450 Nerve Stimulator?
The StimPod NMS450 Nerve Stimulator must be stored in its original packaging to maintain sterility. It is MRI-unsafe and should not be used in MRI environments.
What regulatory approvals does the StimPod NMS450 Nerve Stimulator have?
The StimPod NMS450 Nerve Stimulator has FDA clearance via a 510(k) submission (K102084), and is regulated under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR).
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 | K102084 | Class II | Active |
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Manufacturer
- Manufacturer
- Xavant Technology (pty) Ltd
- FDA Applicant
- Xavant Technology (Pty), Ltd.
Sources (2)
- FDA 510(k) K102084 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026