The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Biotek Inc..
| Device ID | K112392 |
| 510k Number | K112392 |
| Device Name: | HIVOX BIOTEK INC. |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2012-03-19 |
| Summary: | summary |