StimPod NMS450 Nerve Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213049 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 classified as a nerve stimulator. It delivers controlled electrical impulses to stimulate peripheral nerves, aiding in nerve conduction studies, diagnostic assessments, and procedural guidance in anesthesiology applications. Designed for precision, it supports clinical evaluations of nerve function and response.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as operating rooms or diagnostic laboratories. It adheres to regulatory standards including FDA 510(k) clearance, MDD, and MDR compliance, ensuring safety and performance. The StimPod NMS450 is not intended for MRI environments and requires proper storage to maintain functionality. Authorisations include K-number K213049 and product code BXN.
Frequently asked questions
Is the StimPod NMS450 nerve stimulator designed for single-use or can it be reused in clinical settings?
The StimPod NMS450 is explicitly described as a reusable medical instrument, intended for use in clinical environments like operating rooms or diagnostic laboratories. Since it is not labeled as single-use, proper cleaning and maintenance protocols must be followed to ensure safety and functionality between uses.
What regulatory pathways has the StimPod NMS450 nerve stimulator undergone, and which advisory committee was involved?
The StimPod NMS450 has received FDA 510(k) clearance (K-number K213049) under the Traditional 510(k) review pathway, with a Substantially Equivalent (SESE) determination. The device was reviewed by the Anesthesiology (AN) Advisory Committee, reflecting its primary application in anesthesiology procedures.
Can the StimPod NMS450 nerve stimulator be used in an MRI environment, or are there specific storage requirements?
The device is not intended for use in MRI environments, as explicitly stated in the manufacturer’s documentation. To maintain functionality, it requires proper storage—though specific conditions (e.g., temperature, humidity) are not detailed, adherence to general medical device storage guidelines is implied to preserve performance.
What medical specialties or clinical applications is the StimPod NMS450 primarily associated with?
The StimPod NMS450 is primarily associated with anesthesiology, as indicated by its OpenFDA classification under medical specialty (Anesthesiology) and the Anesthesiology Advisory Committee (AN) review. It is designed for nerve conduction studies, diagnostic assessments, and procedural guidance, supporting evaluations of nerve function and response in clinical settings.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213049 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xavant Technology (pty) Ltd
- FDA Applicant
- Xavant Technology (Pty), Ltd.
Sources (2)
- FDA 510(k) K213049 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026