FDA.reportPublic FDA data

KDY2

Primary DI
B733KDY20
Brand
KDY2
Company
Sigma Instruments, Inc.
Model
SA-201
Device description
Adjusting instrument
Published
2022-12-28
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
K962239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962239000SMART ADJUSTER (SA201)Sigma1997-01-10LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B733KDY20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint/spinal manipulator, electronicA hand-held, electrically-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 electromechanical instrument is typically pistol-like in shape and uses a plunger-like mechanism to deliver thrust to the patient's body with a single or double rubber-tipped stylus; it typically has several force settings. This is a reusable device.

Regulatory Flags#

DUNS number
049391241
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B733KDY10KDY1SA-2012022-12-28
B733KDYST0KDY-STSA-2012022-12-28

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
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
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