The following data is part of a premarket notification filed by Avazzia, Inc. with the FDA for Body-stim, Biomodulator, Best-rsi, Best Pro, Model Best-av1.
| Device ID | K062641 |
| 510k Number | K062641 |
| Device Name: | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AVAZZIA, INC. 13154 COIT RD., STE. 200 Dallas, TX 75240 |
| Contact | Catherine Tone |
| Correspondent | Catherine Tone AVAZZIA, INC. 13154 COIT RD., STE. 200 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 | 2006-09-06 |
| Decision Date | 2007-04-30 |
| Summary: | summary |