SunMed
DC 5-2014-- NO Replacement--Micro Stim Overlay
2manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K121743 |
| Record published | 2016-09-21 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Storage | Special storage condition: Do not get wet. Keep out of direct sunlight. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-1053-82 | In distribution | |
| 8-1053-PL | In distribution | |
| 8-1053-RD | In distribution | |
| 8-1053-FS | In distribution | |
| 8-1053-TL | In distribution | |
| 8-1053-84 | In distribution | |
| 8-1053-83 | In distribution | |
| 8-1053-GN | In distribution | |
| 8-1053-63 | In distribution | |
| 8-1053-GR | In distribution | |
| 8-1053-62 | In distribution | |
| 8-1053-81 | In distribution | |
| 8-1053-BL | In distribution | |
| 8-1053-95 | In distribution | |
| 8-1053-OR | In distribution | |
| 8-1053-85 | In distribution | |
| 8-1053-60 | In distribution | |
| 8-1053-78 | In distribution | |
| 8-1053-PK | In distribution | |
| 8-1051-78 | In distribution | |
| 8-1053-76 | In distribution | |
| 8-1051-79 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Bioness | Xavant Technology (PTY) Ltd | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121743 | 2013-03-28 |
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.