FDA.reportPublic FDA data

CAT Pro Select

Primary DI
G041CT0120
Brand
CAT Pro Select
Company
JTECH Medical
Model
CT012
Device description
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
Published
2021-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXMManipulator, Plunger-Like Joint

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXMManipulator, Plunger-Like JointUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974376000JTECH ADJUSTER REFLEX GUNJ-Tech Medical, Inc.1998-02-18LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G041CT0120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint/spinal manipulator, mechanicalA hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more force settings. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G041CT0010Original CATCT0012021-05-14
G041CT0060CAT EXCT0062021-05-14
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
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
00860011416494ProAdjuster KidzNeuromechanical Innovations, L.L.C.LXM2025-05-01
00860011416487Prosoft SRTNeuromechanical Innovations, L.L.C.LXM2024-02-08
00086001141645Prosoft GTNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416401Impulse Adjusting InstrumentNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416418Impulse iQ Adjusting InstrumentNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416463Prosports 360Neuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416470ProAdjuster SRTNeuromechanical Innovations, L.L.C.LXM2024-01-13
00855341008006PulStarSense Technology, Inc.LXM2023-07-03
10855341008003PulStarSense Technology, Inc.LXM2023-07-03
B733KDY10KDY1Sigma Instruments, Inc.LXM2022-12-28
B733KDY20KDY2Sigma Instruments, Inc.LXM2022-12-28
B733KDYST0KDY-STSigma Instruments, Inc.LXM2022-12-28
B854M20Khan Kinetic Treatment Device (KKT-M2)Optima Health Solutions International CorporationLXM2022-03-24
G041CT0010Original CATJTECH MedicalLXM2021-05-14
G041CT0060CAT EXJTECH MedicalLXM2021-05-14
00850021303013Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303020Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303044Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303051Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303082Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303099Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303105Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303112Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303129Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303136Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
10381780168959Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
10381780168966Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
10381780168980Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
10381780168997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
H834015996000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12