MultiStim ECO
MultiStim Eco is a handheld, battery-powered peripheral nerve stimulator for anesthesia procedures in adults. It delivers pulses through a connected stimulation needle to help identify or…
MultiStim Eco is a handheld, battery-powered peripheral nerve stimulator for anesthesia procedures in adults. It delivers pulses through a connected stimulation needle to help identify or locate a nerve.
The needle connects directly to the device by a stimulation cable. The stimulator attaches to an adhesive electrode through a pushbutton connection, allowing one-handed operation of its keypad.
Listed Item
MultiStim ECO plastic case incl. battery.
Pulse Controls
Frequency is fixed at 1 Hz and pulse width at 0.1 milliseconds. Current is adjustable in six steps from 0.2 to 2.0 mA. A stimulation button activates or stops the pulses independently of switching on the unit. The needle and anesthetic delivery components are separate from the stimulator.
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 | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K162086 |
| Record published | 2020-11-11 |
| Record revised | 2024-12-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 10 to 65 % RH |
| Distribution end date | 2025-03-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1151-94-21 | Withdrawn | |
| 1151-94-21 | Withdrawn | |
| 1151-94-50 | Withdrawn | |
| 1151-94-50 | Withdrawn |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 Sensor PatientCable | Pajunk Gmbh Medizintechnologie | 4 |
| Temena | Temena GmbH | 2 |
| Bioness | Xavant Technology (PTY) Ltd | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162086 | 2017-01-06 |
| K061172 | 2006-10-17 |
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.