Zida Zida Control Device
Zida Zida Control Device (1472) is a Class II device made by Exodus Innovation Ltd, cleared under FDA 510(k) K192731 on 19 Mar 2021 and listed in FDA GUDID since 5 May 2022 (UDI-DI 07297539014728), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07297539014728 | Date5 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192731 | Date19 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 07297539014728
- FDA 510(k) database K192731
Across registries
- FDA 510(k) K192731 decided 19 Mar 2021 Active
- FDA GUDID UDI-DI 07297539014728 listed 5 May 2022 Listed
Timeline
- Cleared FDA 510(k) K192731
- Listed FDA GUDID 07297539014728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zida
- Generic name
- Sacral plexus implantable incontinence-control electrical stimulation system
- Model / Ref / Catalog
- Zida Control Device, 1472
- Primary DI / UDI-DI
- 07297539014728
- 510(k) Number
- FDA product code
- NAM
- GMDN term
- Sacral plexus implantable incontinence-control electrical stimulation system
- Device class
- Class II
- Regulation number
- 876.5310
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction).
- URGENT PC STIMULATOR; URGENT PC LEAD SET by Uroplasty, LLC
- URGENT PC NEUROMODULATION SYSTEM by Uroplasty, LLC
- ZIDA Wearable Neuromodulation System by Exodus Innovations
- NURO NEUROMODULATION SYSTEM by Advanced Uro-Solutions, Inc.
- UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE by Urosurge, Inc.
- Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application by Avation Medical, Inc.