Identifiers
- 510(k) Number
- K822814 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 EMG 100T is a biofeedback device classified under product code HCC and regulation number 882.5050. It is a substantially equivalent device cleared through the traditional 510(k) pathway with K number K822814.
The device is manufactured by Thought Technology Ltd. and is authorized for use in the United States. It falls under the neurology advisory committee classification and is intended for use as a biofeedback instrument in clinical or professional settings.
Frequently asked questions
What is the EMG 100T used for?
The EMG 100T is intended for use as a biofeedback instrument in clinical or professional settings, specifically within neurology, to provide physiological feedback for training or therapeutic purposes based on electromyographic signals.
How was the EMG 100T authorized for market release?
The EMG 100T received authorization through the traditional 510(k) pathway as a substantially equivalent device, with clearance granted under K number K822814, based on its similarity to legally marketed predicate devices.
What regulatory classification applies to the EMG 100T?
The EMG 100T is classified under product code HCC and regulation number 882.5050, placing it in Class II for biofeedback devices, as indicated by its FDA submission and neurology advisory committee review.
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. Sources consulted: EMG 100T 510 (k) K822814 - FDA.report, Thought Technology, PDF Reference Manual - Thought Technology, Thought Technology EMG and Physiological Systems, Cables, Gels & Adapters - Current Technology, Inc
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K822814 | Class II | Active |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
- FDA Applicant
- Thought Technology , Ltd.
Sources (1)
- FDA 510(k) K822814 24 fields · synced Sep 22, 2026