The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Hivox Otc Electrical Stimulator.
| Device ID | K171803 |
| 510k Number | K171803 |
| Device Name: | HIVOX OTC Electrical Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hivox Biotek Inc. 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, TW 24158 |
| Contact | Linda Lin |
| Correspondent | Linda Lin Hivox Biotek Inc. 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 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 | 2017-06-19 |
| Decision Date | 2017-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20050428302969 | K171803 | 000 |