Device recall
Z-0205-2018: Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air…
FDA device recall · Class II · Won Industry Co.
Key facts
| Recall number (Z-number) | Z-0205-2018 |
|---|---|
| Recall event | 78182 |
| Product | Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device… |
| Product code | IRP |
| Recalling firm | Won Industry Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2023 |
| 510(k) numbers | K120166 |
| FEI number | 3005515255 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database