FDA.reportPublic FDA data

510(k) K050428

Device
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
Applicant
Advanced Spinal Technologies, Inc.
510(k) number
K050428
Product code
LXM
Decision
Substantially Equivalent (SESE)
Decision date
2005-06-14
Date received
2005-02-18
Classification name
Manipulator, Plunger-Like Joint
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY R PERELMAN
Address
433 Plz. Real, Suite 255 Boca Raton FL US 33432 33432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K234036SONIK MONARK 100Neuro Spinal Innovation, Inc.2024-02-15
K192629SpinalyticsOptima Health Solutions International Corp.2019-12-21
K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc.2018-06-20
K160278VSTAAR AdjusteRSpinal Acoustics, LLC2016-11-04
K130666KHAN KINETIC TREATMENT (KKT-M2)Optima Health Solutions International Corporation2014-01-23
K112606ACTIVATOR V-EActivator Methods International, Ltd.2012-03-06
K082218MAX ADJUSTING INSTRUMENTManna Omni International, Inc.2008-08-13
K080261IMPULSE IQ ADJUSTING INSTRUMENTNeuromechanical Innovations, LLC2008-04-11
K072519ACTIVATOR V SPINAL ADJUSTING INSTRUMENTActivator Methods International, Ltd.2007-10-23
K060043KHAN KINETIC TREATMENT DEVICE (KKT-M1)Optima Health Solutions International, Inc.2006-03-23
K023462IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003Neuromechanical Innovations, LLC2003-01-13
K021238FRYE ADJUSTING INSTRUMENTFrye Health Systems2002-10-09
K010851HARRISON HAND HELD ADJUSTING INSTRUMENTHarrison Cbp Seminars2001-09-18
K003185FS ACTIVATOR IIIActivator Methods International, Ltd.2001-03-20
K001476TORQUE INSTRUMENT, MODEL 8500Spinalight, Inc.2000-08-04