AccessGUDID - DEVICE: NeckCare Assessments (05694230564002)

GUDID

Device Identifier (DI) Information

Brand Name: NeckCare Assessments
Version or Model: v1.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NeckCare Holding ehf

Primary DI Number: 05694230564002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 500824286 *Terms of Use
Previous DI: 05694230564019

Device Description: The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47518	Biomechanical function analysis/rehabilitation software	A software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQX	Goniometer, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 70 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79d58039-332f-4543-a9d8-ff2cba953b3f
Public Version Date: June 09, 2025
Public Version Number: 1
DI Record Publish Date: May 30, 2025