The following data is part of a premarket notification filed by Avazzia, Inc. with the FDA for Avazzia.
| Device ID | K162392 |
| 510k Number | K162392 |
| Device Name: | Avazzia |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | AVAZZIA, INC. 13140 COIT ROAD SUITE 515 Dallas, TX 75240 |
| Contact | Tammy Lahutsky |
| Correspondent | Tammy Lahutsky AVAZZIA, INC. 13140 COIT ROAD SUITE 515 Dallas, TX 75240 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-05-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AVAZZIA 87915894 5654081 Live/Registered |
Avazzia, Inc. 2018-05-10 |