FDA-Device2023-11-01Class II
SOZO Bilateral Arm L-Dex Software
Impedimed Limited
Hazard
Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.
Sold states
US Nationwide distribution in the states of IA, CA, IL, AK, NY, FL, KS, WI, MI, NC, GA, SD, KY, TX, MA, LA, AZ, RI, AR, CO, WY, OH, IN, MO, NJ, MD, CT, WA, PA, UT, VA, NM, ME, MN, DC, TN, NE, OR, ND, WV.
Affected count
354
Manufactured in
Building, U 1 50 Parker Ct, Pinkenba, N/A, Australia
Products
SOZO Bilateral Arm L-Dex Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2024Don't want to check this manually?
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