HCC

Product Code: HCC


Products Classified as HCC

3721Device, BiofeedbackBiofeedback Device.

Total Product Life Cycle (TPLC) Devices

3721Device, BiofeedbackBiofeedback Device.

FDA Consensus Standards

Device, Biofeedback [32789]21 CFR §882.5050 🔎

Pre-market Notifications for HCC

K180173FreespiraPalo Alto Health Sciences, Inc.
K163448GrindCare SystemSUNSTAR SUISSE S.A.
K151050Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC
K143507NFANT Feeding SolutionNFANT Labs, LLC
K131586CANCARY BREATHING SYSTEMPALO ALTO HEALTH SCIENCES, INC.
K122879EEGER4 MODEL 4.3EEG SOFTWARE LLC
K111687EMG SYSTEMMYOTRONICS-NOROMED, INC.
K092675GRINDCAREMEDOTECH A/S
K073557EEG NEUROAMP, MODEL CS10137CORSCIENCE GMBH & CO. KG
K071866NTRAINER SYSTEMKCBIOMEDIX, INC.
K071661ALPHAONE BIOFEEDBACK SYSTEMTELEDIAGNOSTIC SYSTEMS, INC.
K041244POLYGRAM NET BIOFEEDBACK APPLICATIONMEDTRONIC VASCULAR
K020399RESPERATE; MODEL RR-150INTERCURE LTD.
K013399MODEL MES-9000/EMG SYSTEMMYOTRONICS-NOROMED, INC.
K012384EAR MUFFINSBIO-LOGIC SYSTEMS CORP.

Global Unique Device Identification Database

00816271020155Device, Biofeedback
00816271020148Device, Biofeedback
00816271020131Device, Biofeedback
00816271020124Device, Biofeedback
00816271020117Device, Biofeedback
00816271020100Device, Biofeedback
00816271020094Device, Biofeedback
00816271020087Device, Biofeedback
00816271020063Device, Biofeedback
00816271020056Device, Biofeedback
00816271020049Device, Biofeedback
00885859004962Device, Biofeedback
00864267000421Device, Biofeedback
00861410000246Device, Biofeedback
00861410000239Device, Biofeedback

Maude Adverse Events

NEUROPTIMAL ADVANCED BRAIN TRAINING SYSTEMUNK2019-07-15
NEURO FEEDBACK MACHINEUNK2019-07-09
MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEMMEDSPIRA LLC2019-06-07
NEUROPTIMAL 3UNK2019-04-03
MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETERMEDSPIRA LLC2019-03-06
MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETERMEDSPIRA LLC2019-03-06
NEUROFEEDBACK EEGUNK2018-11-20
BRAIN ENTRAINMENT SOFTWAREBRAINCORE2017-03-01
GUM DROP INFANT PACIFIERNATUS MEDICAL INC.2017-01-27
GUM DROP INFANT PACIFIERNATUS MEDICAL INC.2017-01-27
GUN DROP FULL TERM PACIFIERNATUS MEDICAL INC.2017-01-24
CYGNET EEGBEE SYSTEMS2016-05-01
NEUROINTEGRATOR 2 AMPLIFIER/PHOTOSONIX PHOTICSTIMULATION GLASSESCLEAR MIND CENTER/PHOTOSONIX2016-03-09
BIOFEEDBACK DEVICEOCHSLABS2016-02-26
NEUROFEEDBACKEEG INFO2016-02-24
NEUROFEEDBACK CYGNET EEG2015-04-28
LOW ENERGY NEUROFEEDBACK SYSTEMOCH LABS2014-04-21
REFLEXION CATHETERST. JUDE MEDICAL, INC. (AF-MINNETONKA)2014-01-27
NEURX DIAPHRAGM PACING SYSTEMSYNAPSE BIOMEDICAL INC.2013-10-08
HCC-882.50 OR UNKNOWNUNK2013-04-19
NEURX DIAPHRAGM PACING SYSTEMSYNAPSE BIOMEDICAL INC.2012-09-07
NEUROFEEDBACK2012-02-06
BRAIN STATE TECHNOLOGIESBRAIN STATE TECHNOLOGIES2011-11-11
NU SKIN PHARMANEXNUSKIN2011-10-18
NEURX DIAPHRAGM PACING SYSTEMSYNAPSE BIOMEDICAL INC.2011-07-06
NEURX DIAPHRAGM PACING SYSTEMSYNAPSE BIOMEDICAL INC.2011-04-18
NEURX DIAPHRAGM PACING SYSTEMSYNAPSE BIOMEDICAL INC.2009-12-14
VIBE2008-12-16
BRAIN STATE CONDITIONBRAIN STATE CONDITION2008-08-25
EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROIDECLOSION KFT2007-07-26
MYSELFDESCHUTES MEDICAL PRODUCTS, INC.2007-01-16
THE ZAPPER*2006-12-15
MYSELFDESCHUTES MEDICAL PRODUCTS INC.2006-12-05
EEG TREATMENT (FLEXYX NEUROTHERAPY SYSTEM)NEUROTHERAPY CENTER OF WASHINGTON, INC.2006-05-04
JOURNEY TO THE WILD DIVINE*2006-04-19
TENNANT BIOMODULATORAVAZZIA2005-11-09
BEST PRO 1AVAZZIA2005-11-09
POCKET-NEUROBICSPOCKET-NUROBICS2005-10-02
BIOCOMP RESEARCH INSTITUTEBIOCOMP RESEARCH INSTITUTE2005-10-02
BIOCOMP OR POCKET NEUROBICS HEGBIOCOMP RESEARCH INST2005-08-29
"RIFE MACHINE"*2005-07-27
SOFT COLD LASER, LOW LEVEL, HELIUM NEON THERAPY*2005-07-27
QXEI-SEIO*2004-07-09
*COMPUTER DIAGNOSTIC SCREENING*2004-05-14
PHARMANEXPHARMANEX, INC.2003-02-05
PHARMANEX BIOPHOTONIC SCANNERPHARMANEX, INC.2002-09-09
BODYSCAN 2010PHAZX SYSTEMS, INC.2001-10-10
MRM/BFDENRICH CORP.1998-07-21
MYOEXORCISER IIIVERIMED, INC.1996-02-09
INTERRO BIOENERGETIC TESTING DEVICESTANDARD ENZYME CO.1994-07-16
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