NormaTec products are FDA-cleared via a 510(k) as a Class II medical device.

We are also proud to hold the following certifications:

	TUVus (tested to UL 60601 for Medical Devices)
	CE Marking
	Exemplary Provider Accredited The Compliance Team Nationally-Recognized Accrediting Body Authorized by the Centers for Medicare and Medicaid Services (CMS)