FDA.reportPublic FDA data

Echo Algometer

Primary DI
G0419RF3070
Brand
Echo Algometer
Company
JTECH Medical
Model
9RF307
Device description
A device to assist the clinician with establishing an objective assessment of a person’s pressure threshold and pain tolerance. The device is intended to be non-invasive, non-surgical and transient.
Published
2021-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRWDynamometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRWDynamometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0419RF3070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pressure algometer, electronicA hand-held, electronic instrument designed to measure a patient's sensitivity to pain (pain threshold) through manual application of a measured mechanical force to the skin. It typically consists of a patient-contact tip, and a strain gauge where results are displayed digitally. Also referred to as a pressure algesimeter or algesiometer, it is typically used to evaluate the effects of pain after the use of analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
385-695-5000support@jtechmedical.com

Regulatory Flags#

DUNS number
625089131
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G041CT0010Original CATCT0012021-05-14
G041CT0060CAT EXCT0062021-05-14
G041CT0120CAT Pro SelectCT0122021-05-14
G0419CM1130Dualer IQ Pro Primary Inclinometer9CM1132021-05-14
G0419CM1140Dualer IQ Pro Secondary Inclinometer9CM1142021-05-14
G0419RF3030Echo Primary Inclinometer9RF3032021-05-14
G0419RF3040Echo Secondary Inclinometer9RF3042021-05-14
G0419RF3050Echo Muscle Tester9RF3052021-05-14
G0419RF3060Echo Grip Gauge9RF3062021-05-14
G0419RF3080Echo Goniometer9RF3082021-05-14
G0419RF3090Echo Pinch Gauge9RF3092021-05-14
G0419RF3100Echo Static Force Gauge9RF3102021-05-14
G0419RF4030Northstar Echo Primary Inclinometer9RF4032021-05-14
G0419RF4040Northstar Echo Secondary Inclinometer9RF4042021-05-14
G0419RF4050Northstar Echo Muscle Tester9RF4052021-05-14
G0419RF4060Northstar Echo Grip Gauge9RF4062021-05-14
G0419RF4070Northstar Echo Algometer9RF4072021-05-14
G0419RF4080Northstar Echo Goniometer9RF4082021-05-14
G0419RF4090Northstar Echo Pinch Gauge9RF4092021-05-14
G0419RF4100Northstar Echo Static Force Gauge9RF4102021-05-14

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