K150353 is an FDA 510(k) clearance for the BTL-4000. This device is classified as a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMG).
Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on November 13, 2015, 275 days after receiving the submission on February 11, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5860.
| 510(k) Number | K150353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2015 |
| Decision Date | November 13, 2015 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5860 |