The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Self Adhesive Electrode Gel Pads.
| Device ID | K131720 |
| 510k Number | K131720 |
| Device Name: | HIVOX SELF ADHESIVE ELECTRODE GEL PADS |
| Classification | Electrode, Cutaneous |
| Applicant | HIVOX BIOTEK, INC. 8 F., NO. 98, SHINDE RD, SANCHONG DISTRICT New Taipei City, TW 24158 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HIVOX BIOTEK, INC. 8 F., NO. 98, SHINDE RD, SANCHONG DISTRICT New Taipei City, TW 24158 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-12 |
| Decision Date | 2014-07-25 |
| Summary: | summary |