Bioness
The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous electrodes or needles (not supplied).
2manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Xavant Technology (PTY) Ltd, South Africa |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Manufacturer |
| 510(k) | K140853 |
| Record published | 2025-02-17 |
| Record revised | 2025-08-28 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C; Handling environment temperature 10 to 90 % RH |
| Distribution end date | 2025-03-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STIMPOD ST2-3100 Stimulation Adapter Cable | In distribution | |
| STIMPOD ST2-3000 KIT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Xavant Technology | Xavant Technology (PTY) Ltd | 14 |
| Stimuplex® | B. Braun Medical Inc. | 12 |
| AincA® | Anesthesia Associates, Inc. | 9 |
| Halyard | Avanos Medical, Inc. | 8 |
| Avanos | Avanos Medical, Inc. | 8 |
| Stimpod | Xavant Technology (PTY) Ltd | 6 |
| Multistim Vario | Pajunk Gmbh Medizintechnologie | 6 |
| Multistim Sensor | Pajunk Gmbh Medizintechnologie | 5 |
| MultiStim ECO | Pajunk Gmbh Medizintechnologie | 4 |
| MultiStim Sensor PatientCable | Pajunk Gmbh Medizintechnologie | 4 |
| Temena | Temena GmbH | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213049 | 2022-10-16 |
| K140853 | 2014-11-06 |
| K110118 | 2011-02-17 |
| K102084 | 2010-12-16 |
| K093591 | 2009-12-03 |
| K072092 | 2007-11-15 |
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.