The following data is part of a premarket notification filed by Integrated Healing Technologies with the FDA for Newera Small Reva Kit, Newera Medium Reva Kit, Newera Large Reva Kit.
| Device ID | K143301 |
| 510k Number | K143301 |
| Device Name: | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Integrated Healing Technologies 103 Forrest Crossing Blvd. Suite 103 Franklin, TN 37064 |
| Contact | Ian Baird |
| Correspondent | Ian Baird Integrated Healing Technologies 103 Forrest Crossing Blvd. Suite 103 Franklin, TN 37064 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-03-03 |
| Summary: | summary |