The following data is part of a premarket notification filed by Therasigma, Llc with the FDA for Etd4000.
| Device ID | K202725 |
| 510k Number | K202725 |
| Device Name: | ETD4000 |
| Classification | Interferential Current Therapy |
| Applicant | TheraSigma, LLC 4060 South Grant St. Suite 102 Washougal, WA 98671 |
| Contact | Jim Klett |
| Correspondent | Jim Klett TheraSigma, LLC 4060 South Grant St. Suite 102 Washougal, WA 98671 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-17 |
| Decision Date | 2021-03-26 |