DPNCheck 2.0
DPNCheck 2.0 Device
1manufacturer
1catalogue number
7510(k) clearances naming this product code
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 | Neurometrix, Inc., United States |
|---|---|
| FDA product code | JXE |
| Device type | Device, Nerve Conduction Velocity Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1550 |
| Establishment | Manufacturer |
| Record published | 2022-12-20 |
| Record revised | 2026-05-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 50 °C |
| Distribution end date | 2025-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NC-040 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070109 | 2008-04-25 |
| K060584 | 2006-07-31 |
| K041320 | 2004-08-12 |
| K013459 | 2002-01-17 |
| K003508 | 2001-01-17 |
| K000565 | 2000-06-27 |
| K982359 | 1998-10-02 |
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.