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Sign in to claim this brandAvation Medical, Inc.
US
Last updated May 25, 2026
What Avation Medical, Inc. makes
Avation Medical, Inc. manufactures transcutaneous incontinence-control electrical stimulators, including the Vivally System—a wearable, non-invasive neuromodulation device paired with a mobile application.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Avation Medical, Inc. manufacture?
Avation Medical, Inc. specializes in transcutaneous incontinence-control electrical stimulators. These devices are designed to help manage urinary incontinence through non-invasive neuromodulation. The company’s primary product line includes the Vivally System, which combines a wearable device with a mobile application for user control and monitoring.
Where is Avation Medical, Inc. based?
Avation Medical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries list Avation Medical’s devices?
Avation Medical’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class II devices, which require additional scrutiny due to their moderate risk.
How are Avation Medical’s devices classified under FDA regulations?
Avation Medical’s devices fall under Class II classification by the FDA. This classification is assigned based on the risk level of the product—Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
What distinguishes Avation Medical’s Vivally System from other incontinence-control solutions?
The Vivally System is a wearable, non-invasive neuromodulation device paired with a mobile application, setting it apart from traditional incontinence solutions. Unlike invasive treatments (e.g., sacral nerve stimulators), it delivers electrical stimulation transcutaneously (through the skin) to modulate nerve activity, aiming to reduce urinary urgency and incontinence episodes without surgery or implants.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 081061890
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vivally | VCG-KDS01 | FDA UDI | Class II | Active |
| Vivally | VCG-KDM01 | FDA UDI | Class II | Active |
| Vivally | VCG-GAS01 | FDA UDI | Class II | Active |
| Vivally | VCG-GC301 | FDA UDI | Class II | Active |
| Vivally | VCG-GAM01 | FDA UDI | Class II | Active |
| Vivally | VCG-SRN01 | FDA UDI | Class II | Active |
| Vivally | VCG-KTS01 | FDA UDI | Class II | Active |
| Vivally | VPG-KTS01 | FDA UDI | Class II | Active |
| Vivally | VCG-GC501 | FDA UDI | Class II | Active |
| Vivally | VCG-KTM01 | FDA UDI | Class II | Active |
| Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | K220454 | FDA 510(k) | Class II | Active |
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