Identifiers
- 510(k) Number
- K881416 FDA 510(k)
- FDA Product Code
- HCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5050 FDA 510(k)
- Regulation Number
- 882.5050 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Myotrac is a biofeedback device designed to monitor and provide real-time feedback on muscle activity. It is classified as a biofeedback device and is used primarily for neurological applications, enabling users to observe and control physiological signals related to muscle function, often for therapeutic or research purposes.
The Myotrac is supplied as a reusable medical device and is intended for use in clinical or research settings. It operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for biofeedback devices. The device is not specified as MRI-safe or single-use, and its storage conditions are not detailed in the provided data. It is categorized under device class 2 and is associated with neurology specialties.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K881416 | Class II | Active |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
- FDA Applicant
- Thought Technology , Ltd.
Sources (2)
- FDA 510(k) K881416 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026