Anesthesiology
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- 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)
Show All 32 Submissions
- 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
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Spinalytics
- Page Type
- Cleared 510(K)
- 510(k) Number
- K192629
- 510(k) Type
- Traditional
- Applicant
- Optima Health Solutions International Corp.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/2019
- Days to Decision
- 89 days
- Submission Type
- Summary