Device product
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Z-2325-2021
Product summary
- Firm
- Ortho8, Inc.
- Event
- Event 88308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2325-2021
Official wording
Reason: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Code information: All Lots
Distribution pattern: 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.
Derived failure modes
-
Unknown
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance