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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- K230444Talee, Talee PostOp2Cleared 510(K)
- K223238STARband 3D2Cleared 510(K)
- K220681Talee, Talee PostOP2Cleared 510(K)
- K203134Hanger Cranial Band 3D2Cleared 510(K)
- K213587MyCRO Band2Cleared 510(K)
- K193383SnugKap2Cleared 510(K)
- K201426MyCRO Band2Cleared 510(K)
- K180568KidCap2Cleared 510(K)
- K141842STARBAND, STARLIGHT2Cleared 510(K)
- K140353STARBAND AND STARLIGHT2Cleared 510(K)
- K133397P-POD2Cleared 510(K)
- K111609BOSTON BAND2Cleared 510(K)
- K111247CRANIAL REMOLDING ORTHOSIS2Cleared 510(K)
- K103362AOI CRANIAL HELMET2Cleared 510(K)
- K090341MICHIGAN CRANIAL RESHAPING ORTHOSIS2Cleared 510(K)
- K070694CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)2Cleared 510(K)
- K063133CRANIAL SOLUTION ORTHOSIS2Cleared 510(K)
- K063395O&P BIVALVE CRANIAL MOLDING HELMET2Cleared 510(K)
- K042385DOC BAND-POSTOP2Cleared 510(K)
- K041215CRANIAL HELMET2Cleared 510(K)
- K021594COPC BAND2Cleared 510(K)
- K013452DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS2Cleared 510(K)
- K030669PROVIDENCE MOLDING HELMET2Cleared 510(K)
- K023572LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET2Cleared 510(K)
- K022273CRANIAL SYMMETRY SYSTEM2Cleared 510(K)
- K021221O&P CRANICAL MOLDING HELMET2Cleared 510(K)
- K020448STATIC CRANIOPLASTY ORTHOSIS2Cleared 510(K)
- K013719BECKER BAND CRANIAL REMOLDING ORTHOSIS2Cleared 510(K)
- K013700ORTHOSIS HELMET MOLDING2Cleared 510(K)
- K012804PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS2Cleared 510(K)
- K012920MOLDED CRANIAL HELMET2Cleared 510(K)
- K012830LERMAN & SON CRANIAL ORTHOSIS HELMET2Cleared 510(K)
- K013458CRANIAL HELMET2Cleared 510(K)
- K012007RHS HELMET2Cleared 510(K)
- K011433BALLERT CRANIAL MOLDING HELMET2Cleared 510(K)
- K003035CLARREN HELMET2Cleared 510(K)
- K003630DANMAR PRODUCTS MICHIGAN CRANIAL HELMET2Cleared 510(K)
- K010273CRANIAL MOLDING ORTHOSIS2Cleared 510(K)
- K001669HANGER CRANIAL BAND2Cleared 510(K)
- K000861CRANIOCAP2Cleared 510(K)
- K001167OPI BAND2Cleared 510(K)
- DEN980001DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND2Cleared 510(K)
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BALLERT CRANIAL MOLDING HELMET
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K011433
- 510(k) Type
- Traditional
- Applicant
- GEMA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/12/2001
- Days to Decision
- 33 days
- Submission Type
- Statement