Device recall
Z-1435-2009: WalkAide Stimulator System Control Module, Part Number 20-0100; component of the…
FDA device recall · Class II · Innovative Neurotronics, Inc.
Key facts
| Recall number (Z-number) | Z-1435-2009 |
|---|---|
| Recall event | 52049 |
| Product | WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a… |
| Product code | GZI |
| Recalling firm | Innovative Neurotronics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2009 |
| 510(k) numbers | K052329 |
| FEI number | 3005694504 |
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