The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Btl-4000.
| Device ID | K150353 |
| 510k Number | K150353 |
| Device Name: | BTL-4000 |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | BTL INDUSTRIES, INC 47 Loring Drive Framingham, MA 01702 |
| Contact | Jan Zarsky |
| Correspondent | Jan Zarsky BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
| Product Code | IMG |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | ILY |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-11-13 |
| Summary: | summary |