The following data is part of a premarket notification filed by Theratech, Inc. with the FDA for If True Sine Interferential Stimulator, Model Wl-2206a.
| Device ID | K050847 |
| 510k Number | K050847 |
| Device Name: | IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A |
| Classification | Stimulator, Muscle, Powered |
| Applicant | THERATECH, INC. 1109 MYATT BLVD. Madison, TN 37115 |
| Contact | Michael Price |
| Correspondent | Michael Price THERATECH, INC. 1109 MYATT BLVD. Madison, TN 37115 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-04 |
| Decision Date | 2005-06-17 |
| Summary: | summary |