FDA.reportPublic FDA data

Khan Kinetic Treatment Device (KKT-M2)

Primary DI
B854M20
Brand
Khan Kinetic Treatment Device (KKT-M2)
Company
Optima Health Solutions International Corporation
Model
KKT-M2
Catalog number
M2
Device description
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K130666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130666000KHAN KINETIC TREATMENT (KKT-M2)Optima Health Solutions International Corporation2014-01-23LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B854M20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-905-2850005info@kktspinetreatment.com

Regulatory Flags#

DUNS number
204132596
Device count
1
Serial number
true
Manufacturing date on label
true

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
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