Identity
- Trade Name
- Radlink Sensor FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SENSOR FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866389000174 FDA UDI
- FDA Product Code
- KQX FDA UDI
- GMDN Term
- Electronic goniometer/kinesiology sensor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic goniometer/kinesiology sensor
Radlink Sensor by Radlink, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radlink, Inc.
Sources (1)
- FDA UDI 6bb72b61-becb-428a-95bf-01880e32e003 33 fields · synced May 30, 2026