The following data is part of a premarket notification filed by Avazzia, Inc. with the FDA for Best-av2 Pro-sport(tm).
| Device ID | K123099 |
| 510k Number | K123099 |
| Device Name: | Best-AV2 Pro-Sport(tm) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AVAZZIA, INC. 13140 Coit Rd Ste 515 Dallas, TX 75240 |
| Contact | Tammy Lahutsky |
| Correspondent | Tammy Lahutsky AVAZZIA, INC. 13140 Coit Rd Ste 515 Dallas, TX 75240 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2014-05-23 |
| Summary: | summary |