AccessGUDID - DEVICE: Northstar Echo Grip Gauge (G0419RF4060)

GUDID

Device Identifier (DI) Information

Brand Name: Northstar Echo Grip Gauge
Version or Model: 9RF406
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JTECH Medical

Primary DI Number: G0419RF4060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625089131 *Terms of Use

Device Description: A device to assist the clinician with establishing an objective assessment of a person’s physical strength. The device is intended to be non-invasive, non-surgical and transient.

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):	No
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?
33785	Hand dynamometer/pinchmeter, electronic	An electrically-powered instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRW	Dynamometer, Nonpowered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc5f79a8-5679-4586-991a-837ea90c88db
Public Version Date: May 24, 2021
Public Version Number: 1
DI Record Publish Date: May 14, 2021