Changsha Anxiang Medical Technology Co., Ltd. · Class II · Cleared Jun 13, 2025
| K-number | K250759 |
| Device name | 3 in 1 TENS UNIT |
| Applicant | Changsha Anxiang Medical Technology Co., Ltd. |
| Product code | NGX |
| Device class | Class II |
| Decision date | Jun 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5850 |
The 3 in 1 TENS UNIT (Models TS2301 and TS2321) is a powered muscle stimulator cleared for two uses: (1) temporary relief of pain from sore and aching muscles in the shoulder, waist, back, neck, upper and lower extremities, abdomen, and bottom due to strain from exercise or household work; and (2) stimulation of healthy muscles to improve and facilitate muscle performance. It is marketed as an over-the-counter device.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The document confirms the device is substantially equivalent to legally marketed predicate devices but does not provide the specific technological comparisons, testing data, or detailed reasoning used to reach this determination. That information would be contained in the 510(k) submission itself, which is not included in this clearance letter.
View the full FDA submission: accessdata.fda.gov