The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Electric Stimulator Otc Tens.
| Device ID | K140650 |
| 510k Number | K140650 |
| Device Name: | HIVOX ELECTRIC STIMULATOR OTC TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HIVOX BIOTEK, INC. 8 F.,NO. 98, SHINDE RD., SANCHONG CITY Taipei Hsien, TW 24158 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HIVOX BIOTEK, INC. 8 F.,NO. 98, SHINDE RD., SANCHONG CITY Taipei Hsien, TW 24158 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-13 |
| Decision Date | 2014-06-27 |
| Summary: | summary |