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Sign in to claim this brandINNARA HEALTH, INC.
US
Last updated May 23, 2026
What INNARA HEALTH, INC. makes
Innara Health, Inc. develops evoked-potential graphic recording systems, including devices branded as Innara Health and NTrainer. These systems are designed to measure and analyze neural responses, primarily for clinical and research applications in neurodiagnostics.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Innara Health, Inc. manufacture?
Innara Health, Inc. specializes in evoked-potential graphic recording systems, which are devices designed to measure and analyze neural responses. These systems are primarily used in clinical and research settings for neurodiagnostics, helping assess brain function through visual recordings of neural activity.
Where is Innara Health, Inc. based?
Innara Health, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries list Innara Health’s devices?
Innara Health’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, allowing healthcare providers and regulators to verify product details and compliance.
How are Innara Health’s devices classified under FDA regulations?
Innara Health’s devices fall under Class II classification according to FDA guidelines. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as evoked-potential systems used in neurodiagnostics.
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
- 809608719
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Innara Health | IN-5001 | FDA UDI | Class II | Active |
| Innara Health | IN-5004 | FDA UDI | Class II | Active |
| Innara Health | M00045 | FDA UDI | Class II | Active |
| Innara Health | M00046 | FDA UDI | Class II | Active |
| Innara Health | IN-5000 | FDA UDI | Class II | Active |
| NTrainer | A10002 | FDA UDI | Class II | Active |
| NTrainer | A10002 | FDA UDI | Class II | Active |
| Innara Health | IN-5002 | FDA UDI | Class II | Active |
| NTrainer | A00002 | FDA UDI | Class II | Active |
| Innara Health | IN-5003 | FDA UDI | Class II | Active |
| NTrainer | A00002 | FDA UDI | Class II | Active |
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