Medical Device Manufacturer · US , St Louis , MO

Hi-Dow International, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2011

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hi-Dow International, Inc. Neurology ✕

4 devices

1-4 of 4

Cleared Jan 19, 2024

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

Neurology · 88d

Cleared Jul 02, 2019

Wrap accessory electrodes

Neurology · 113d

Cleared Aug 04, 2017

Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Neurology · 245d

Cleared May 13, 2011

Neurology · 245d