510(k) K220454
- Device
- Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- Applicant
- Avation Medical, Inc.
- 510(k) number
- K220454
- Product code
- NAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-03
- Date received
- 2022-02-17
- Regulation
- 876.5310
- Classification name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Manish Vaishya
- Address
- 1375 Perry St. Columbus OH US 43201 43201
FDA Registration Numbers#
- 3027578962
- 3021071765
- 3002647932
- 2183164
- 3018094310
- 2183613
- 3003477135
- 2182207
Source Documents#
Other 510(k) Records For Product Code NAM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021-03-19 |
| K132561 | NURO NEUROMODULATION SYSTEM | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | 2010-10-21 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | 2007-08-20 |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Uroplasty, Inc. | 2006-07-03 |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | 2005-10-17 |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Urosurge, Inc. | 2000-02-09 |