ZIDA Wearable Neuromodulation System
FDA 510(k) clearance K192731 · decided 2021-03-19
Clearance details
- K-number
- K192731
- Device name
- ZIDA Wearable Neuromodulation System
- Applicant
- Exodus Innovations
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2021-03-19
- Days to decision
- 539 days
- Clearance type
- Traditional
- Product code
- NAM
- Device class
- 2
- Regulation number
- 876.5310
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sufa, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (K220454) | Avation Medical, Inc. | 2023-04-03 |
| NURO NEUROMODULATION SYSTEM (K132561) | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| URGENT PC STIMULATOR; URGENT PC LEAD SET (K101847) | Uroplasty, Inc. | 2010-10-21 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (K071822) | Uroplasty, Inc. | 2007-08-20 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 (K061333) | Uroplasty, Inc. | 2006-07-03 |
| URGENT PC NEUROMODULATION SYSTEM (K052025) | Uroplasty, Inc. | 2005-10-17 |
| UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (DEN000002) | Urosurge, Inc. | 2000-02-09 |
Recalls involving this device
No recalls on record reference this clearance.