Company ยท US
Hi-Dow International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2024 | K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) Hi-Dow International, Inc. | NUH |
| Nov 12, 2021 | K210383 | Wrap Accessory Electrodes Hi-Dow International, Inc. | GXY |
| Dec 15, 2020 | K202337 | Pulsed electromagnetic field wrap Hi-Dow International, Inc. | ILX |
| Jul 2, 2019 | K190617 | Wrap accessory electrodes Hi-Dow International, Inc. | GXY |
| Aug 4, 2017 | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) Hi-Dow International, Inc. | NUH |
| May 13, 2011 | K102598 | HI-DOW-XP Hi-Dow International, Inc. | NUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||