Identifiers
- 510(k) Number
- K834519 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 Calmtone is a biofeedback device, classified under the product code HCC, with a regulation number of 882.5050. It falls under the medical specialty of Neurology.
The Calmtone is supplied by Thought Technology Ltd. and has received FDA 510(k) clearance, with the decision description being Substantially Equivalent. The device has a specific K number, K834519, and is associated with various registration numbers and FEI numbers as listed in the openfda device information.
Frequently asked questions
What is the Calmtone device used for?
The Calmtone is a biofeedback device used in the medical specialty of Neurology.
Is the Calmtone device FDA cleared?
Yes, the Calmtone has received FDA 510(k) clearance, with a decision description of Substantially Equivalent, under the K number K834519.
What product code is the Calmtone device classified under?
The Calmtone is classified under the product code HCC, with a regulation number of 882.5050.
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: CALMTONE (K834519) — FDA 510 (k) | Innolitics, Thought Technology, Calmtone - Beudamed, Thought-Technology FDA Filings - FDA.report, Biofeedback - Page 1 - Thought Technology Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K834519 | Class II | Active |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
- FDA Applicant
- Thought Technology , Ltd.
Sources (1)
- FDA 510(k) K834519 24 fields · synced Sep 27, 2026