US Medical Innovations
Canady Helios Cold Plasma Ablation System
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | US Medical Innovations, LLC, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K240297 |
| Record published | 2024-06-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XL-1000CP | 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 Generator | Galvanize Therapeutics | 1 |
| Aliya Electrode | Galvanize Therapeutics | 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 |
|---|---|
| K240297 | 2024-05-03 |
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.