E-Vive Nmes System
e-vive NMES System; with Post-Op Brace; Extra Small, Right
4manufacturers in China registered for this device type
9catalogue 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 | Motive Health, Inc., United States |
|---|---|
| FDA product code | KQX |
| Device type | Goniometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K163067 |
| Record published | 2018-05-01 |
| Record revised | 2023-06-02 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature -25 to 70 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -25 to 70 °C |
| Sizes | Length 16 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CY-1000-121 | Length 16 in | In distribution |
| CY-1000-053 | Length 16 in | In distribution |
| CY-1000-050 | Length 16 in | In distribution |
| CY-1000-119 | In distribution | |
| CY-1000-052 | Length 16 in | In distribution |
| CY-1000-120 | Length 16 in | In distribution |
| CY-1000-122 | Length 16 in | In distribution |
| CY-1000-051 | Length 16 in | In distribution |
| CY-1000-046 | Length 16 in | 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 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.