FDA-Device2021-08-25Class II

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Ortho8, Inc.
Hazard

EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

Sold states
US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.
Affected count
N/A
Manufactured in
2217 Plaza Dr, N/A, Rocklin, CA, United States
Products
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2021

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