Argo Medical Technologies Ltd
FDA Regulatory Profile
Argo Medical Technologies Ltd appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1553-2021, Class II) was initiated on February 28, 2020. Its most recent 510(k) clearance was granted on June 26, 2014.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1553-2021 | Class II | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs a | February 28, 2020 |
| Z-0944-2018 | Class II | ReWalk Personal 6.0. Catalog number: 50-20-0004. | August 14, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN130034 | REWALK | June 26, 2014 |