The following data is part of a premarket notification filed by Slk Medical Gmbh with the FDA for V12 Pro.
| Device ID | K210913 |
| 510k Number | K210913 |
| Device Name: | V12 PRO |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | SLK Medical GmbH Am Herdicksbach 18 Waltrop, DE 45731 |
| Contact | Matthew Reid |
| Correspondent | Matthew Reid SLK Medical GmbH Am Herdicksbach 18 Waltrop, DE 45731 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-08-04 |