Changsha Anxiang Medical Technology Co., Ltd. · Class II · Cleared Jul 28, 2025
| K-number | K251187 |
| Device name | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) |
| Applicant | Changsha Anxiang Medical Technology Co., Ltd. |
| Product code | NUH |
| Device class | Class II |
| Decision date | Jul 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
The 3 in 1 TENS UNIT (models TC1241, TC2241, TS1241) is a transcutaneous electrical nerve stimulation device designed for temporary relief of pain from sore and aching muscles in various body areas (shoulder, back, neck, limbs, abdomen) due to strain from exercise or household activities. It also functions as an electrical muscle stimulator (EMS) to stimulate healthy muscles and improve muscle performance. The device is marketed over-the-counter for consumer use.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The FDA determination letter confirms substantial equivalence to legally marketed predicate TENS devices predating May 28, 1976, or reclassified devices, but the specific predicate device(s), comparative testing, or technical equivalence reasoning is not detailed in this clearance summary document.
View the full FDA submission: accessdata.fda.gov