K190251 is an FDA 510(k) clearance for the RecoveryRx. This device is classified as a Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (Class II - Special Controls, product code ILX).
Submitted by Bioelectronics Corporation (Frederick, US). The FDA issued a Cleared decision on June 28, 2019, 141 days after receiving the submission on February 7, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K190251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2019 |
| Decision Date | June 28, 2019 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILX - Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |