← Product Code [NUH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH) · K221384

# Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (K221384)

_Hivox Biotek, Inc. · NUH · Jun 11, 2022 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K221384

## Device Facts

- **Applicant:** Hivox Biotek, Inc.
- **Product Code:** [NUH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH.md)
- **Decision Date:** Jun 11, 2022
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 882.5890
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K221384](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K221384)

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