FDA Certifications

The US Food and Drug Administration (FDA) clearance process is rigorous, especially for drugs and medical devices. At Zynex Medical, quality and service come first, therefore all of our products are FDA cleared to ensure we deliver quality medical devices to our clients and patients.

EWave-FDA Cleared
EMS3000-FDA_510k_Clearance.pdf

IF8000-FDA Cleared
IF8000-FDA_510k_Clearance.pdf

TruWave-FDA Cleared
TruWave-FDA_510k_Clearance.pdf

NeuroMove-FDA Cleared
NeuroMove-FDA_510k_Clearance.pdf

ValuTens III-FDA Cleared
ValuTens_III-FDA_510k_Clearance.pdf