Kinvent
Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.
4manufacturers in China registered for this device type
1catalogue number
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 | Kinvent Hellas, Greece |
|---|---|
| FDA product code | KQX |
| Device type | Goniometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1500 |
| Establishment | Remanufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-01 |
| Record revised | 2021-11-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 40 °C; Storage environment temperature -10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sens V2R01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultium | Noraxon U.S.A., Inc. | 16 |
| MyoVision Wirefree System | Precision Biometrics, Inc. | 13 |
| 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 |
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.