Identity
- Trade Name
- NeckCare System FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- The NeckCare System is used to measure, record, analyze and report head motion during instructed head-neck movements. FDA UDI
- Model / Reference
- NS-110X2 FDA UDI
- Description
- The NeckCare System is used to measure, record, analyze and report head motion during instructed head-neck movements. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05694230564019 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic goniometer/kinesiology sensor
NeckCare System by NeckCare Holding ehf — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic goniometer/kinesiology sensor.
- myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes — FUTURE HEALTH WORKS LTD · Class I
- ROMI Dual Inclinometer System — Lafayette Instrument Company · Class I
- E-LINK N100 Small Goniometer — BIOMETRICS LIMITED · Class II
- XACT Robotics: Respiration Sensor All Around Strap — XACT ROBOTICS LTD · Class II
- MotionSense Knee Alignment Block — ENMOVI LTD · Class I
- MotionSense Knee Alignment Block — ENMOVI LTD · Class I
- Titronics — Titronics Research & Development Co. · Class I
- Digital Knee® — OPUM TECHNOLOGIES SERVICES LIMITED · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NeckCare Holding ehf
Sources (1)
- FDA UDI ee1f7b5d-df4c-4771-9cdf-43669c23d69d 34 fields · synced May 30, 2026