Argo Medical Technologies Ltd

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1553-2021Class IIReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs aFebruary 28, 2020
Z-0944-2018Class IIReWalk Personal 6.0. Catalog number: 50-20-0004.August 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
DEN130034REWALKJune 26, 2014