Changsha Anxiang Medical Technology Co., Ltd. · Class II · Cleared Mar 12, 2025
| K-number | K243763 |
| Device name | Wireless TENS & EMS Unit |
| Applicant | Changsha Anxiang Medical Technology Co., Ltd. |
| Product code | NGX |
| Device class | Class II |
| Decision date | Mar 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5850 |
The Wireless TENS & EMS Unit is a wearable electrical stimulation device designed for two purposes: (1) TENS mode for temporary relief of pain from sore and aching muscles in various body locations due to strain from exercise or household work, and (2) EMS mode to stimulate healthy muscles to improve or facilitate muscle performance. The device is cleared for over-the-counter use.
Not stated in this summary. The document does not provide specific technological specifications, such as frequency ranges, pulse widths, electrode configurations, wireless communication protocols, or other distinguishing technical features compared to the predicate device.
Not stated in this summary. The document does not cite specific test methods, consensus standards (ISO, IEC, ASTM, etc.), or performance testing protocols that were used to evaluate the device.
Not stated in this summary. The clearance letter confirms substantial equivalence but does not provide the detailed reasoning, comparison table, or technical justification explaining how this device compares to the predicate device(s) in terms of design, materials, function, or performance characteristics.
View the full FDA submission: accessdata.fda.gov