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Sign in to claim this brandNeuros Medical, Inc.
US
Last updated May 25, 2026
What Neuros Medical, Inc. makes
Neuros Medical, Inc. manufactures implantable systems for spinal cord and peripheral nerve stimulation, including wired leads, pulse generators, and control units designed to deliver electrical analgesia. Their portfolio also covers associated hardware such as battery chargers, programmer tools, and software for managing stimulation devices. Additional components include cuffs in varying sizes and port plugs for implantable pulse generators, alongside a dedicated programming application for patient controllers.
All devices produced by the company fall under Class III regulatory classification in the US, requiring Premarket Approval (PMA) or Unique Device Identification (UDI) registration. These products are listed in the FDA’s regulatory databases under PMA and UDI pathways. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Neuros Medical, Inc. manufacture?
Neuros Medical, Inc. specializes in implantable systems for managing pain through electrical stimulation. Their devices include wired leads for spinal cord or peripheral nerve stimulation, implantable pulse generators (IPGs), control units, and battery chargers. They also produce accessories like cuffs (in small, medium, and large sizes), port plugs for IPGs, and software applications for programming and managing stimulation devices. These systems are designed to deliver targeted electrical analgesia.
Where is Neuros Medical, Inc. based, and how does that affect its regulatory standing?
Neuros Medical, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations. The FDA classifies all of Neuros Medical’s products as Class III, which means they require either Premarket Approval (PMA) or Unique Device Identification (UDI) registration before commercial distribution. This classification reflects the higher risk associated with implantable devices.
Which regulatory databases list Neuros Medical, Inc.’s devices, and why?
Neuros Medical, Inc.’s devices are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) databases. This is because Class III devices—such as those used for spinal cord or peripheral nerve stimulation—require rigorous pre-market authorization to ensure safety and effectiveness. The PMA pathway confirms clinical evidence, while UDI registration ensures traceability and compliance tracking throughout the device’s lifecycle.
How are Neuros Medical, Inc.’s devices classified under US regulations, and what does that mean for patients or healthcare providers?
Neuros Medical, Inc.’s devices are classified as Class III under US regulations. This classification is the highest risk tier and applies to devices that sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury if they fail. As a result, these devices must undergo Premarket Approval (PMA)—a thorough review process involving clinical trials and evidence of safety and efficacy—before they can be legally marketed. This ensures that only well-vetted products reach patients.
Are Neuros Medical, Inc.’s devices part of any public registries, and what information can be found there?
Yes, Neuros Medical, Inc.’s devices are included in the FDA’s regulatory databases, specifically under Premarket Approval (PMA) and Unique Device Identification (UDI) listings. These registries provide details such as device descriptions, regulatory status, manufacturer information, and compliance history. For example, the UDI database allows tracking of individual devices post-market, ensuring transparency in supply chains and recall management. The PMA listings include clinical study summaries and approval documentation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 829526081
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Altius Cuff Medium | FG-600-002 | FDA UDI | Class III | Active |
| Altius Patient Controller | FG-604-000 | FDA UDI | Class III | Active |
| Altius Cuff Large | FG-600-003 | FDA UDI | Class III | Active |
| Altius Programmer Wand | FG-606-000 | FDA UDI | Class III | Active |
| Altius IPG | FG-601-000 | FDA UDI | Class III | Active |
| Altius IPG Accessory Kit | FG-610-000 | FDA UDI | Class III | Active |
| Altius Battery Charger | FG-603-000 | FDA UDI | Class III | Active |
| Altius Programming Application PC | FG-608-000 | FDA UDI | Class III | Active |
| Altius Cuff Small | FG-600-001 | FDA UDI | Class III | Active |
| Altius® Direct Electrical Nerve Stimulation System | P230020 | FDA PMA | Class III | Active |
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