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NeckCare Assessments

FDA UDI

Class I (US FDA UDI)

by NeckCare Holding ehf

Identity

Trade Name
NeckCare Assessments FDA UDI
Generic Name
Biomechanical function analysis/rehabilitation software FDA UDI
Device Name
The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements. FDA UDI
Model / Reference
v1.1 FDA UDI
Description
The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements. FDA UDI

Identifiers

Primary DI / UDI-DI
05694230564002 FDA UDI
FDA Product Code
KQX FDA UDI
GMDN Term
Biomechanical function analysis/rehabilitation software 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

Yes

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: Biomechanical function analysis/rehabilitation software

NeckCare Assessments by NeckCare Holding ehf — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biomechanical function analysis/rehabilitation software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NeckCare Holding ehf

Sources (1)

  • FDA UDI 79d58039-332f-4543-a9d8-ff2cba953b3f 34 fields · synced May 30, 2026