The following data is part of a premarket notification filed by Innovamed Health, Llc with the FDA for Venapro Vascular Therapy System.
| Device ID | K193020 |
| 510k Number | K193020 |
| Device Name: | VenaPro Vascular Therapy System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Innovamed Health, LLC 270 West 500 North North Salt Lake, UT 84054 |
| Contact | Luke Zeutzius |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 20505 Valley Blvd. Suite 108 Walnut, CA 91789 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-30 |
| Decision Date | 2019-12-04 |