The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Dreamate Dm-800.
| Device ID | K021952 |
| 510k Number | K021952 |
| Device Name: | HIVOX DREAMATE DM-800 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-13 |
| Decision Date | 2003-05-02 |