The following data is part of a premarket notification filed by Bioelectronics Corporation with the FDA for Recoveryrx.
| Device ID | K190251 |
| 510k Number | K190251 |
| Device Name: | RecoveryRx |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | BioElectronics Corporation 4539 Metropolitan Ct Federick, MD 21704 |
| Contact | Sree N Koneru |
| Correspondent | Sree N Koneru BioElectronics Corporation 4539 Metropolitan Ct Federick, MD 21704 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2019-06-28 |