Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- K234036SONIK MONARK 100UCleared 510(K)
- K192629SpinalyticsUCleared 510(K)
- K172536Atlas Percussion Adjusting InstrumentUCleared 510(K)
- K160278VSTAAR AdjusteRUCleared 510(K)
- K130666KHAN KINETIC TREATMENT (KKT-M2)UCleared 510(K)
- K112606ACTIVATOR V-EUCleared 510(K)
- K082218MAX ADJUSTING INSTRUMENTUCleared 510(K)
- K080261IMPULSE IQ ADJUSTING INSTRUMENTUCleared 510(K)
- K072519ACTIVATOR V SPINAL ADJUSTING INSTRUMENTUCleared 510(K)
- K060043KHAN KINETIC TREATMENT DEVICE (KKT-M1)UCleared 510(K)
- K050428TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)UCleared 510(K)
- K023462IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003UCleared 510(K)
- K021238FRYE ADJUSTING INSTRUMENTUCleared 510(K)
- K010851HARRISON HAND HELD ADJUSTING INSTRUMENTUCleared 510(K)
- K003185FS ACTIVATOR IIIUCleared 510(K)
- K001476TORQUE INSTRUMENT, MODEL 8500UCleared 510(K)
- K973914SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTARUCleared 510(K)
- K974376JTECH ADJUSTER REFLEX GUNUCleared 510(K)
- K973506ACTIVATOR IIUCleared 510(K)
- K962239SMART ADJUSTER (SA201)UCleared 510(K)
- K950646INTEGRATORUCleared 510(K)
- K955540HAND HELD ATLAS INSTRUMENTUCleared 510(K)
- K951217ATLAS ORTHOGONAL PERCUSSION INSTTUMENTUCleared 510(K)
- K946258MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENTUCleared 510(K)
- K944369NEW-STIM SPINAL ADJUSTMENT INSTRUMENTUCleared 510(K)
- K940085FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01UCleared 510(K)
- K930431ARTHROSTIM MANIPULATORUCleared 510(K)
- K922695KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5UCleared 510(K)
- K922694KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4UCleared 510(K)
- K922693KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1UCleared 510(K)
- K922692KINETIC TECHNOLOGY POCKET PRECISION ADJUSTORUCleared 510(K)
- K870910PRECISION SPINAL ADJUSTER MODEL 115UCleared 510(K)
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SMART ADJUSTER (SA201)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K962239
- 510(k) Type
- Traditional
- Applicant
- Sigma
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/10/1997
- Days to Decision
- 213 days
- Submission Type
- Summary