# Heating Tens, FT-615

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/heating-tens-ft-615-nuh>
- Manufacturer: [Hivox Biotek Inc.](https://devicerts.com/manufacturers/hivox-biotek-inc) (Taiwan)
- Device class: Class II (US FDA)
- FDA product code: NUH

## Overview

*AI-generated summary, 2026-09-28. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K232675 · decision 2023-10-05 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K232675 [FDA 510(k)]
- FDA product code: NUH [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 882.5890 [FDA 510(k)]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Heating Tens, FT-615, Hivox Biotek Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/heating-tens-ft-615-nuh (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/heating-tens-ft-615-nuh.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/heating-tens-ft-615-nuh
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.