The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Hivox Otc Electrical Stimulator, Ft610-b.
| Device ID | K211403 |
| 510k Number | K211403 |
| Device Name: | HIVOX OTC Electrical Stimulator, FT610-B |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hivox Biotek Inc. SF., No. 123, Xingde Road, Sanchong District New Taipei City, TW 241 |
| Contact | Ruby Lu |
| Correspondent | Ruby Lu Hivox Biotek Inc. SF., No. 123, Xingde Road, Sanchong District New Taipei City, TW 241 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-10-15 |