MyoVision Wirefree System
PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanVision Lite Static sEMG Scanner
4manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Suga Technology (Dongguan) Co.. Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Visbody Intelligent Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Forethought(Shanghai)Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Precision Biometrics, Inc., United States |
|---|---|
| FDA product code | KQX |
| Device type | Goniometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1500 |
| 510(k) | K123399 |
| Record published | 2016-11-15 |
| Record revised | 2018-07-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D11-D5 FlexLite | In distribution | |
| D11-D7L | In distribution | |
| D3-D6-D7 | In distribution | |
| D11-D6 | In distribution | |
| D11-D7 | In distribution | |
| D3-D5-D6-D7 | In distribution | |
| D11-D5 | In distribution | |
| D3-D5FL-D7 | In distribution | |
| D3-D5-D7 | In distribution | |
| D2-D6 | In distribution | |
| D2-D5-D6 | In distribution | |
| D3-D5-D6 | In distribution | |
| D3-D5-D6-D7L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultium | Noraxon U.S.A., Inc. | 16 |
| e-vive Nmes System | Motive Health, Inc. | 9 |
| e-vive Nmes System with Post-Op Brace; Small/Medium, Left (2.0 Dock) | Motive Health, Inc. | 6 |
| myoMOTION | Noraxon U.S.A., Inc. | 5 |
| Digital Knee® | Opum Technologies Services | 3 |
| MyNotifi Rx | Medhab, LLC | 3 |
| e-vive Nmes System with Post-Op Brace; Large/XL, Left | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; Large/XL, Right | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; 2XL/3XL, Left (2.0 Dock) | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; 2XL/3XL, Right (2.0 Dock) | Motive Health, Inc. | 3 |
| MyoVision Software | Precision Biometrics, Inc. | 3 |
| e-vive Nmes System; Small/Medium, Right | Motive Health, Inc. | 2 |
Showing 12 of 111. All products under Goniometer, Ac-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.