Radlink Sensor
The Radink Sensor uses a combination of a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer to locate a patient's body in 3D space. It is calibrated to the patient's…
The Radink Sensor uses a combination of a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer to locate a patient’s body in 3D space. It is calibrated to the patient’s original position immediately prior to the surgery so any movement is tracked and the patient can be returned to the original position at any time during or after the surgery.
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 | Radlink, Inc., United States |
|---|---|
| FDA product code | KQX |
| Device type | Goniometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SENSOR | 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.