ClearanceBrief
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

CodeDeviceRecords
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter3
GXYElectrode, Cutaneous2
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 19, 2024K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
Hi-Dow International, Inc.
NUH
Nov 12, 2021K210383Wrap Accessory Electrodes
Hi-Dow International, Inc.
GXY
Dec 15, 2020K202337Pulsed electromagnetic field wrap
Hi-Dow International, Inc.
ILX
Jul 2, 2019K190617Wrap accessory electrodes
Hi-Dow International, Inc.
GXY
Aug 4, 2017K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)
Hi-Dow International, Inc.
NUH
May 13, 2011K102598HI-DOW-XP
Hi-Dow International, Inc.
NUH

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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