NormaTec Industries, LP FDA Approvals

0 new drug approvals and 4 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
Normatec Elite Hip510(k)Sep 18, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Sep 18, 2025
Normatec Elite510(k)Mar 21, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Mar 21, 2024
Normatec Go510(k)Jul 14, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jul 14, 2022
Normatec 3510(k)Feb 25, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Feb 25, 2022