Medical device 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 Hi-Dow International, Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jan 19, 2024: Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A).
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.
| Jan 19, 2024 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K233461 · NUH | 510(k) clearances |
| Nov 12, 2021 | Wrap Accessory ElectrodesK210383 · GXY | 510(k) clearances |
| Dec 15, 2020 | Pulsed electromagnetic field wrapK202337 · ILX | 510(k) clearances |
| Jul 2, 2019 | Wrap accessory electrodesK190617 · GXY | 510(k) clearances |
| Aug 4, 2017 | Hi-Dow Wireless TENS/EMS System (Model HD-5N)K163393 · NUH | 510(k) clearances |
| May 13, 2011 | HI-DOW-XPK102598 · NUH | 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
