Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hivox Biotek, Inc. with 18 510(k) clearances. The most recent is a 510(k) clearance dated Jun 16, 2026: TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 16, 2026 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)K260425 · NUH | 510(k) clearances |
| Dec 17, 2024 | POCKET TENS (EP-300)K242815 · NUH | 510(k) clearances |
| Oct 5, 2023 | Heating Tens, FT-615K232675 · NUH | 510(k) clearances |
| May 13, 2023 | HEATING TENS/EMS, FT-810RK223308 · NUH | 510(k) clearances |
| Jun 11, 2022 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2K221384 · NUH | 510(k) clearances |
| Oct 15, 2021 | HIVOX OTC Electrical Stimulator, FT610-BK211403 · NUH | 510(k) clearances |
| Mar 10, 2021 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2K203574 · NUH | 510(k) clearances |
| Nov 8, 2019 | HIVOX Spopad EMS SP-911, SP-921K192264 · NGX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
