For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)…
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)
Who Else Makes It
Concentrated in Guangdong (6), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Well-Life | Listed by | Well-Life Healthcare Limited, Taiwan |
| FDA product code | LIH |
| Device type | Interferential Current Therapy |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K080304 |
| Record published | 2017-05-02 |
| Record revised | 2019-08-07 (version 8) |
Specifications
Specifications | MRI safety | MR Safe |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2019-08-07 |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.