Device recall
Z-2093-2010: The "RS-FBG Full Back Conductive Garment" with electrode attachments for use…
FDA device recall · Class II · International Rehabilitative Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-2093-2010 |
|---|---|
| Recall event | 55578 |
| Product | The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate… |
| Product code | GXY |
| Recalling firm | International Rehabilitative Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2012 |
| 510(k) numbers | K090951 |
| FEI number | 1000117825 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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