AccessGUDID - DEVICE: Northstar Echo Static Force Gauge (G0419RF4100)

GUDID

Device Identifier (DI) Information

Brand Name: Northstar Echo Static Force Gauge
Version or Model: 9RF410
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JTECH Medical

Primary DI Number: G0419RF4100
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?
63454	Dynamometer force gauge	An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.	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: 09ea6cba-d8bc-4823-8c87-c64a034363a8
Public Version Date: May 24, 2021
Public Version Number: 1
DI Record Publish Date: May 14, 2021