K120093 is an FDA 510(k) clearance for the BTL ELITE. This device is classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMJ).
Submitted by BTL Industries, Inc. (Waltham, US). The FDA issued a Cleared decision on October 5, 2012, 267 days after receiving the submission on January 12, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K120093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2012 |
| Decision Date | October 05, 2012 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |