Cascade Iomax Intraoperative Monitor
Cascade IOMAX Cortical Module
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Cadwell Industries, Inc., United States |
|---|---|
| FDA product code | JXE |
| Device type | Device, Nerve Conduction Velocity Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1550 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162199 |
| Record published | 2017-05-31 |
| Record revised | 2025-12-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 190296-200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultra-Drive® Tool | Biomet Orthopedics | 40 |
| Advance | Neurometrix, Inc. | 18 |
| DPNCheck | Impulse Technology LLC | 7 |
| Chalgren | Chalgren Enterprises, Inc. | 5 |
| Rhythmlink® | Rhythmlink International, LLC | 4 |
| Ultra-Drive | Biomet Orthopedics | 3 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| NC-stat DPNCheck | Neurometrix, Inc. | 2 |
| NeMus 1 | EB Neuro SPA | 2 |
| Sierra Wave | Cadwell Industries, Inc. | 2 |
| Cascade | Cadwell Industries, Inc. | 2 |
| NeMus PC Peripheral | EB Neuro SPA | 1 |
Showing 12 of 32. All products under Device, Nerve Conduction Velocity Measurement
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cadwell Industries, Inc. | 510(k) number | 2024-05-17 | Class II | Process design | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation. | 26 units |
| Cadwell Industries, Inc. | 510(k) number | 2024-04-23 | Class II | Process design | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient. | 54 units |
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.