Echo Static Force Gauge

Basic Information

• Brand Name: Echo Static Force Gauge
• Primary DI: G0419RF3100
• Version / Model: 9RF310
• Company Name: JTECH Medical
• Labeler DUNS: 625089131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-14
• Public Version: 1
• Public Version Date: 2021-05-24
• Public Version Status: New
• Public Device Record Key: a3ec7a5e-c22c-41aa-9188-c77e490b82f3

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRW	Dynamometer, Nonpowered	Orthopedic	888.1250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0419RF3100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]