The following data is part of a premarket notification filed by Theratech, Inc. with the FDA for If True Sine Interferential Stimulator / Model Wl-2206a1 & Wi-2206a2.
Device ID | K060975 |
510k Number | K060975 |
Device Name: | IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 |
Classification | Interferential Current Therapy |
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 | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-10 |
Decision Date | 2006-05-10 |
Summary: | summary |