← Product Code [NFO](/productcode/NFO) · K253932

# FACEGYM Pro Device (HD-109) (K253932)

_Shenzhen Kaiyan Medical Equipment Co., Ltd. · NFO · Jul 23, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253932

## Device Facts

- **Applicant:** Shenzhen Kaiyan Medical Equipment Co., Ltd.
- **Product Code:** [NFO](/productcode/NFO.md)
- **Decision Date:** Jul 23, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/device/K253932](https://fda.innolitics.com/device/K253932)

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