The following data is part of a premarket notification filed by Naimco, Inc. with the FDA for Sonic-stim.
| Device ID | K063135 |
| 510k Number | K063135 |
| Device Name: | SONIC-STIM |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
| Contact | Julie Creasman |
| Correspondent | Julie Creasman NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
| Product Code | IMG |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2007-02-05 |
| Summary: | summary |