The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Heating Tens/ems Device, Ft-240-1, Heating Tens/ems Device, Ft-240-2.
| Device ID | K221384 |
| 510k Number | K221384 |
| Device Name: | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hivox Biotek Inc. 5F., No. 123, Xingde Rd., Sanchong Dist. New Taipei City, TW 24158 |
| Contact | Aaron Huang |
| Correspondent | Aaron Huang Hivox Biotek Inc. 5F., No. 123, Xingde Rd., Sanchong Dist. New Taipei City, TW 24158 |
| Product Code | NUH |
| Subsequent Product Code | IRT |
| Subsequent Product Code | NGX |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719880810192 | K221384 | 000 |
| B311PETNEMHT1 | K221384 | 000 |