The following data is part of a premarket notification filed by Vena Group, Llc with the FDA for Venaone.
| Device ID | K200285 |
| 510k Number | K200285 |
| Device Name: | VenaOne |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Vena Group, LLC 10 Westelm Gardens San Antonio, TX 78230 |
| Contact | Kasey Vukson |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-07-02 |