FDA.reportPublic FDA data

Echo Secondary Inclinometer

Primary DI
G0419RF3040
Brand
Echo Secondary Inclinometer
Company
JTECH Medical
Model
9RF304
Device description
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. 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
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0419RF3040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electronic goniometer/kinesiology sensorA small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.

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
G0419RF3050Echo Muscle Tester9RF3052021-05-14
G0419RF3060Echo Grip Gauge9RF3062021-05-14
G0419RF3070Echo Algometer9RF3072021-05-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.KQX2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.KQX2025-10-23
00850004866184ActivForce 2ActivBody, Inc.KQX2025-09-03
05694230564002NeckCare AssessmentsNeckCare Holding ehfKQX2025-05-30
05694230564033NeckCare DeviceNeckCare Holding ehfKQX2025-05-30
09413000126259myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000126273myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000123395Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
09413000123418Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCKQX2024-09-03