Hi-Dow International, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)510(k)Jan 19, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 19, 2024
Wrap Accessory Electrodes510(k)Nov 12, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2021