FDA.reportPublic FDA data

Activator Methods

Primary DI
00850021303136
Brand
Activator Methods
Company
Activator Methods International, Ltd.
Model
ARIV Dark Blue
Device description
Chiropractic Adjusting Instrument
Published
2020-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K003185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003185000FS ACTIVATOR IIIActivator Methods International, Ltd.2001-03-20LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021303136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021303136008500213031368500213031360850021303136

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

Regulatory Flags#

DUNS number
194879383
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021303006Activator MethodsARV2020-10-16
00850021303013Activator MethodsARIV2020-10-16
00850021303020Activator MethodsARII2020-10-16
00850021303044Activator MethodsEZII2020-10-16
00850021303051Activator MethodsEZIV2020-10-16
00850021303082Activator MethodsEZIV Purple2020-10-16
00850021303099Activator MethodsEZIV Blue2020-10-16
00850021303105Activator MethodsEZIV Dark Blue2020-10-16
00850021303112Activator MethodsARIV Purple2020-10-16
00850021303129Activator MethodsARIV Blue2020-10-16

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
G041CT0120CAT Pro SelectJTECH 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
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