Aliya Generator
The Aliya Generator supplies pulsed electric-field energy to the Aliya Ablation Device for surgical ablation of soft tissue. It is a transportable, nonsterile unit for the operating-room…
The Aliya Generator supplies pulsed electric-field energy to the Aliya Ablation Device for surgical ablation of soft tissue. It is a transportable, nonsterile unit for the operating-room environment, forming part of the Aliya System 2.5 with the ablation device and a cardiac monitor.
The generator produces high-frequency, short-duration energy that travels through the connected ablation device to the target tissue. Its hardware and software include a touchscreen, power cord and foot switch, with controls to start or stop treatment and indicators for treatment status and alerts.
Listed Item
Aliya Generator, 2.5
Cardiac Synchronization
The generator interfaces with an Ivy Biomedical Model 7600 cardiac monitor. The monitor detects ECG R-waves and sends trigger signals that synchronize energy delivery with the cardiac cycle. Generator software interprets these triggers and permits delivery only when the heart rate is within its acceptable limits.
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Energenx Medical Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Galvanize Therapeutics, United States |
|---|---|
| FDA product code | OAB |
| Device type | Low Energy Direct Current Thermal Ablation System |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212871 |
| Record published | 2023-08-18 |
| Record revised | 2025-03-03 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GTI-00017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 25 |
| NanoKnife | AngioDynamics, Inc. | 25 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 8 |
| Aliya Needle | Galvanize Therapeutics | 2 |
| Aliya Electrode | Galvanize Therapeutics | 1 |
| US Medical Innovations | US Medical Innovations, LLC | 1 |
| Aliya PEF Ablation Pack | Galvanize Therapeutics | 1 |
| Aliya Generator-Recertified | Galvanize Therapeutics | 1 |
| Inumi Flex Needle | Galvanize Therapeutics | 1 |
| Inumi Flex Needle Pack | Galvanize Therapeutics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253826 | 2026-05-07 |
| K233884 | 2024-05-22 |
| K212871 | 2022-06-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.