Hong Qiangxing (Shenzhen) Electronics Limited · Class II · Cleared Dec 23, 2025
| K-number | K253740 |
| Device name | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) |
| Applicant | Hong Qiangxing (Shenzhen) Electronics Limited |
| Product code | NUH |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
The TENS&EMS device (models HZ9151B, HZ9151C, HZ9151D) is a transcutaneous electrical nerve stimulator for temporary relief of pain in muscles of the shoulder, waist, back, arm, leg, and feet caused by strain from exercise or normal activities. It also includes EMS (electrical muscle stimulation) functionality to stimulate healthy muscles and improve muscle performance.
Not stated in this summary.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov