Identifiers
- 510(k) Number
- K232675 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Heating Tens, FT-615 is a Transcutaneous Nerve Stimulator. It is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter device. The device is used for stimulation.
The Heating Tens, FT-615 is supplied by Hivox Biotek, Inc. and is classified under product code NUH. It received FDA 510(k) clearance under approval number K232675. The device was reviewed by the Neurology advisory committee.
Frequently asked questions
What is the Heating Tens FT-615 used for?
The Heating Tens FT-615 is used for stimulation, as a transcutaneous nerve stimulator.
Is the Heating Tens FT-615 cleared by the FDA?
Yes, the Heating Tens FT-615 received FDA 510(k) clearance under approval number K232675, determined to be substantially equivalent.
How is the Heating Tens FT-615 classified?
The Heating Tens FT-615 is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter device, under product code NUH.
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: PDF Hivox Biotek Inc. Leslie Peng Senior Product Manager Re: K232675, K232675 - Heating Tens, FT-615 - Neurology, Heating Tens, FT-615 — FDA 510 (k) K232675 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232675 | Class II | Active |
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Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- FDA Applicant
- Hivox Biotek, Inc.
Sources (1)
- FDA 510(k) K232675 24 fields · synced Sep 28, 2026