Identity
- Trade Name
- INNOVO FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. FDA UDI
- Model / Reference
- 208 FDA UDI
- Description
- The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. FDA UDI
Identifiers
- Catalog Number
- 0208-5040 FDA UDI
- Primary DI / UDI-DI
- 15391533470982 FDA UDI
- FDA Product Code
- QAJ FDA 510(k)FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.5330 FDA 510(k)
- Regulation Number
- 876.5330 FDA 510(k)FDA UDI
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Innovo by Atlantic Therapeutics, Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192357 | Class II | Active |
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Manufacturer
- Manufacturer
- Atlantic Therapeutics, Ltd.
Sources (2)
- FDA 510(k) K192357 24 fields · synced Jun 18, 2026
- FDA UDI cadf67b4-0c60-46a5-bf2f-ad8e5fe3f2b2 35 fields · synced May 26, 2026