AincA®
Nerve Stimulator, Peripheral, DEMO w/Ball Electrodes, 9v Battery, Lead Set (Alligator), IFU and Zip Case (RED)
2manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Anesthesia Associates, Inc., United States |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K811614 |
| Record published | 2021-03-31 |
| Record revised | 2021-05-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-110-P | In distribution | |
| 00-108-P | In distribution | |
| 00-109 | In distribution | |
| 00-100-PLUS | In distribution | |
| 00-106 | In distribution | |
| 00-100-PLUS-DEMO | In distribution | |
| 00-100-PLUS-KIT | In distribution | |
| 00-107-P | In distribution | |
| 00-112-P | In distribution |
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 |
| 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 |
| Bioness | Xavant Technology (PTY) Ltd | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
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.