The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Activ.a.c. Therapy Unit.
| Device ID | K183543 |
| 510k Number | K183543 |
| Device Name: | ACTIV.A.C. Therapy Unit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc. 6203 Farinon Dr. San Antonio, TX 78249 |
| Contact | Teri Feeley |
| Correspondent | Teri Feeley KCI USA, Inc. 6203 Farinon Dr. San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-03-20 |