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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
K
23
3580
A Breathing System (ABS)
2
Cleared 510(K)
K
22
2101
Prism
2
Cleared 510(K)
K
18
0173
Freespira
2
Cleared 510(K)
K
16
3448
GrindCare System
2
Cleared 510(K)
K
15
1050
Pacifier Activated Lullaby (PAL®)
2
Cleared 510(K)
K
14
3507
NFANT Feeding Solution
2
Cleared 510(K)
K
13
1586
CANCARY BREATHING SYSTEM
2
Cleared 510(K)
K
12
2879
EEGER4 MODEL 4.3
2
Cleared 510(K)
K
11
1687
EMG SYSTEM
2
Cleared 510(K)
K
09
2675
GRINDCARE
2
Cleared 510(K)
K
07
3557
EEG NEUROAMP, MODEL CS10137
2
Cleared 510(K)
K
07
1866
NTRAINER SYSTEM
2
Cleared 510(K)
K
07
1661
ALPHAONE BIOFEEDBACK SYSTEM
2
Cleared 510(K)
K
04
1244
POLYGRAM NET BIOFEEDBACK APPLICATION
2
Cleared 510(K)
K
02
0399
RESPERATE; MODEL RR-150
2
Cleared 510(K)
K
01
0388
SONDREX P.A.L. SYSTEM
2
Cleared 510(K)
K
01
3399
MODEL MES-9000/EMG SYSTEM
2
Cleared 510(K)
K
01
2384
EAR MUFFINS
2
Cleared 510(K)
K
01
2011
MODIFICATION TO A620 EEG
2
Cleared 510(K)
K
01
1964
INSIGHT MILLENNIUM PLUS
2
Cleared 510(K)
K
01
1823
BIOREHAB SYSTEM
2
Cleared 510(K)
K
01
1983
INSIGHT GENESIS
2
Cleared 510(K)
K
00
3367
ORION PLATINUM
2
Cleared 510(K)
K
00
3127
REGAIN DESKTOP
2
Cleared 510(K)
K
00
0405
INTERCURE LTD. RESPI-LOW
2
Cleared 510(K)
K
99
3654
NEUROCOMP
2
Cleared 510(K)
K
99
2439
NORODYN 8000 SEMG SYSTEM, ND-8000
2
Cleared 510(K)
K
99
0778
INSIGHT MILLENNIUM
2
Cleared 510(K)
K
99
0538
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
99
0356
THE BAGNOLI-8 EMG SYSTEM
2
Cleared 510(K)
K
98
3550
XYZ SYSTEM
2
Cleared 510(K)
K
98
1934
THE BAGNOLI-4 EMG SYSTEM
2
Cleared 510(K)
K
98
1844
SLEEP MANAGEMENT SYSTEM
2
Cleared 510(K)
K
98
0373
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
2
Cleared 510(K)
K
97
1400
MUSCLE RESPONSE MONITOR
2
Cleared 510(K)
K
97
1708
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
2
Cleared 510(K)
K
97
3537
PATHWAY ELECTROMYOGRAPH
2
Cleared 510(K)
K
97
2723
BIO TROL
2
Cleared 510(K)
K
97
2487
EMG RETRAINER
2
Cleared 510(K)
K
97
0051
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
2
Cleared 510(K)
K
94
3535
MODEL ME 300 MUSCLE TESTER
2
Cleared 510(K)
K
96
3202
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
2
Cleared 510(K)
K
96
5006
AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)
2
Cleared 510(K)
K
96
1645
MRS-2D
2
Cleared 510(K)
K
96
1718
DEI MODEL 20 EEG
2
Cleared 510(K)
K
96
0761
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
2
Cleared 510(K)
K
95
4737
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
2
Cleared 510(K)
K
96
0762
SYNERGY PLUS
2
Cleared 510(K)
K
95
2797
AT53 DUAL CHANNEL EMG
2
Cleared 510(K)
K
92
4313
DIGITAL CONDUCTANCE METER
2
Cleared 510(K)
K
95
3257
ORALSENSOR
2
Cleared 510(K)
K
95
4127
BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
95
1213
RELAXPLUS
2
Cleared 510(K)
K
94
4615
A620 EEG
2
Cleared 510(K)
K
94
5286
THE BAGNOLI-2 EMG SYSTEM
2
Cleared 510(K)
K
94
2769
BIOINTEGRATOR, BIOINTEGRATOR PLUS
2
Cleared 510(K)
K
94
5826
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
2
Cleared 510(K)
K
95
1350
MUSCLESENSE ELECTROMYOGRAPHY DEVICE
2
Cleared 510(K)
K
94
1959
VERSATELL; VERSATELL-S
2
Cleared 510(K)
K
95
1969
MYOEXORCISER II FUAL
2
Cleared 510(K)
K
93
0578
AT33 EMG
2
Cleared 510(K)
K
93
0577
AT64 SCR
2
Cleared 510(K)
K
93
0576
AT42
2
Cleared 510(K)
K
94
0050
FOCUS EMG
2
Cleared 510(K)
K
92
0038
NEUROSEARCH-4
2
Cleared 510(K)
K
92
5750
RELAXOMAT
2
Cleared 510(K)
K
93
5853
EMG TRAINER
2
Cleared 510(K)
K
92
2270
PHYSIOTECH 4000 OR NORODYN 8000
2
Cleared 510(K)
K
94
1938
THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
2
Cleared 510(K)
K
91
4925
MEDAC SYSTEM/3
2
Cleared 510(K)
K
92
2838
NORODYN 2000 ELECTROMYOGRAPH
2
Cleared 510(K)
K
92
5197
PSI 220 DUAL EMG
2
Cleared 510(K)
K
91
4920
BIOFEEDBACK SYSTEM/3
2
Cleared 510(K)
K
91
5858
MYOTRAC2
2
Cleared 510(K)
K
91
5859
MYOTRAC/S, MYODAC/S
2
Cleared 510(K)
K
91
3898
MYOTRAC+/S, MYODAC+/S
2
Cleared 510(K)
K
91
1911
MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
2
Cleared 510(K)
K
91
2595
AXIOM ELECTROMYOGRAPH
2
Cleared 510(K)
K
89
7132
PATHWAY II ELECTROMYOGRAPH
2
Cleared 510(K)
K
90
5372
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
2
Cleared 510(K)
K
90
5373
MINIATURE TEMPERATURE TRAINER MODEL DT-002
2
Cleared 510(K)
K
90
3497
FLEXCOMP DSP & PROCOMP
2
Cleared 510(K)
K
90
2450
BODYLOG ENHANCED STRESS REDUCTION PACKAGE
2
Cleared 510(K)
K
89
6409
M(3):MICRO MUSCLE MONITOR
2
Cleared 510(K)
K
90
0639
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
2
Cleared 510(K)
K
89
5635
MYOSYSTEM 1000 ELECTROMYOGRAPH
2
Cleared 510(K)
K
89
5633
MYOTRACE 10 BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
89
4510
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
2
Cleared 510(K)
K
89
0500
ELT OR ERGONOMIC LIFT TRAINER
2
Cleared 510(K)
K
89
2649
VERIMED MYOEXORCISER III (MYO III)
2
Cleared 510(K)
K
89
4840
MYODAC2 BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
89
2114
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
2
Cleared 510(K)
K
89
1693
AUTOMATED THERAPY SYSTEM
2
Cleared 510(K)
K
88
1164
LEUNOMED RFB 5000
2
Cleared 510(K)
K
88
4849
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
2
Cleared 510(K)
K
88
4851
BIOFEEDBACK DEVICE TG3, TG4
2
Cleared 510(K)
K
88
4852
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
2
Cleared 510(K)
K
88
4850
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
2
Cleared 510(K)
K
88
4848
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
2
Cleared 510(K)
K
88
4853
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
2
Cleared 510(K)
K
88
4135
DM100 (DISTAL MONITOR - 100)
2
Cleared 510(K)
K
88
3597
MYODAC
2
Cleared 510(K)
K
88
1416
MYOTRAC
2
Cleared 510(K)
K
88
2266
DIGITAL EMG MONITOR MYOTRON 120
2
Cleared 510(K)
K
88
2062
MODEL BIOSTAR
2
Cleared 510(K)
K
88
0914
T824 TEMPERATURE MONITOR
2
Cleared 510(K)
K
88
0916
M444 EMG MONITOR
2
Cleared 510(K)
K
88
0913
M424 EMG MONITOR
2
Cleared 510(K)
K
87
3834
INET MODEL BIOVISION
2
Cleared 510(K)
K
87
5308
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
2
Cleared 510(K)
K
87
3418
BODYLOG STRESS REDUCTION PACKAGE
2
Cleared 510(K)
K
87
2495
BIOCOMP 2001 BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
87
0568
BIO-PROMPT(TM)
2
Cleared 510(K)
K
87
0793
SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
86
1950
THE FM-212A BIOFEEDBACK UNIT
2
Cleared 510(K)
K
86
0271
BIOFEEDBACK MICROLAB
2
Cleared 510(K)
K
85
4277
NEUROPATH 4000
2
Cleared 510(K)
K
85
2963
MYO-ACTUATOR
2
Cleared 510(K)
K
85
4208
THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS
2
Cleared 510(K)
K
85
3806
MA-400 EMB FEEDBACK DEVICE
2
Cleared 510(K)
K
85
0849
MYOMETER EMG BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
85
0759
COMPUTER INTERFACE - BIOFEEDBACK
2
Cleared 510(K)
K
85
0642
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
2
Cleared 510(K)
K
85
0643
HR/BVP 100T HEART RATE MONITOR
2
Cleared 510(K)
K
84
3738
CAB2 COMPUTER ASSISTED BIOFEEDBACK
2
Cleared 510(K)
K
84
3413
STRESS CONTROL BIOFEEDBACK CARD
2
Cleared 510(K)
K
84
2021
EEG BIOFEEDBACK DEVICE ACCESSORY
2
Cleared 510(K)
K
84
2023
TEMP. & GSR BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
84
2022
EEG BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
84
2353
TEMPERATURE 132
2
Cleared 510(K)
K
84
2288
EEG 130
2
Cleared 510(K)
K
84
1895
GSR, 126, EEG 130-TEMP. 132, EMG 133
2
Cleared 510(K)
K
84
2354
EMG MODEL 133
2
Cleared 510(K)
K
84
1128
RELAX STRESS REDUCTION SYS
2
Cleared 510(K)
K
84
0223
ORION BIOFEEDBACK DATA ACQUISITION
2
Cleared 510(K)
K
83
4110
ANTENSE ANTI-TENSION DEVICE
2
Cleared 510(K)
K
83
4111
ANTACHE ANTI-HEADACHE DEVICE
2
Cleared 510(K)
K
83
4519
CALMTONE
2
Cleared 510(K)
K
83
2714
VERIMED MYOEXORCISER
2
Cleared 510(K)
K
83
2333
FEEDBACK EMG SYSTEM PE-020
2
Cleared 510(K)
K
83
2146
TA-400 TEMP. FEEDBACK DEVICE
2
Cleared 510(K)
K
83
2122
ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED
2
Cleared 510(K)
K
82
3511
EMG BIOFEEDBACK DEVICE
2
Cleared 510(K)
K
83
0529
BIOFEEDBACK-TRAINING INSTRUMENT
2
Cleared 510(K)
K
82
3381
PROFESSIONAL MARK I BIOFEEDBACK SYS
2
Cleared 510(K)
K
82
3146
CALMSET 3 TM
2
Cleared 510(K)
K
82
2814
EMG 100T
2
Cleared 510(K)
K
81
2619
ISOLATED VOLTAGE/FREQUENCY CONVERTER
2
Cleared 510(K)
K
81
2179
LIFE-TECH #1753 BIOFEEDBACK TRAINER
2
Cleared 510(K)
K
81
0882
ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A
2
Cleared 510(K)
K
81
0881
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
2
Cleared 510(K)
K
81
0880
AR-1 PHYSIOLOGICAL PRODESSOR
2
Cleared 510(K)
K
81
0332
SC/TEMP 300
2
Cleared 510(K)
K
80
3099
BIOFEEDBACK BIO 80
2
Cleared 510(K)
K
80
2390
EMG-UT 30
2
Cleared 510(K)
K
80
2391
EMG-UT 40
2
Cleared 510(K)
K
80
1049
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
2
Cleared 510(K)
K
80
0319
ALPHA DETECTOR
2
Cleared 510(K)
K
79
2115
BIOFEEDBACK DEVICES & ACCESSORIES
2
Cleared 510(K)
K
79
2659
FEEDBACK EDR SYSTEM MODEL ME-1
2
Cleared 510(K)
K
79
1207
APOLLO HEART RATE INDICATOR
2
Cleared 510(K)
K
79
0746
THE BIONIC EXERCISER
2
Cleared 510(K)
K
78
1634
VISUALAX
2
Cleared 510(K)
K
78
0436
RELAX-A-TONE
2
Cleared 510(K)
K
77
1577
CLINICAL EMG MODEL 133
2
Cleared 510(K)
K
77
1023
ANALOG QUANTIFIER MODEL AQ-100
2
Cleared 510(K)
K
77
0787
RELAXATION COURSE MOLEL 1000
2
Cleared 510(K)
K
77
0790
FEEDBACK EDR SYSTEM MODEL EDR-100
2
Cleared 510(K)
K
77
0663
FEEDBACK EMG SYSTEM, MODEL PE-L00
2
Cleared 510(K)
K
76
1350
MYOTRON
2
Cleared 510(K)
K
77
0270
TEMPERATURE FEEDBACK SYS, MODEL DT100
2
Cleared 510(K)
K
76
0084
MONITOR, GSR (NB-401)
2
Cleared 510(K)
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
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/
subpart-f—neurological-therapeutic-devices
/
HCC
/
K992439
View Source
NORODYN 8000 SEMG SYSTEM, ND-8000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992439
510(k) Type
Special
Applicant
MYOTRONICS-NOROMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/13/1999
Days to Decision
22 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
K
23
3580
A Breathing System (ABS)
K
22
2101
Prism
K
18
0173
Freespira
K
16
3448
GrindCare System
K
15
1050
Pacifier Activated Lullaby (PAL®)
K
14
3507
NFANT Feeding Solution
K
13
1586
CANCARY BREATHING SYSTEM
K
12
2879
EEGER4 MODEL 4.3
K
11
1687
EMG SYSTEM
K
09
2675
GRINDCARE
K
07
3557
EEG NEUROAMP, MODEL CS10137
K
07
1866
NTRAINER SYSTEM
K
07
1661
ALPHAONE BIOFEEDBACK SYSTEM
K
04
1244
POLYGRAM NET BIOFEEDBACK APPLICATION
K
02
0399
RESPERATE; MODEL RR-150
K
01
0388
SONDREX P.A.L. SYSTEM
K
01
3399
MODEL MES-9000/EMG SYSTEM
K
01
2384
EAR MUFFINS
K
01
2011
MODIFICATION TO A620 EEG
K
01
1964
INSIGHT MILLENNIUM PLUS
K
01
1823
BIOREHAB SYSTEM
K
01
1983
INSIGHT GENESIS
K
00
3367
ORION PLATINUM
K
00
3127
REGAIN DESKTOP
K
00
0405
INTERCURE LTD. RESPI-LOW
K
99
3654
NEUROCOMP
K
99
2439
NORODYN 8000 SEMG SYSTEM, ND-8000
K
99
0778
INSIGHT MILLENNIUM
K
99
0538
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K
99
0356
THE BAGNOLI-8 EMG SYSTEM
K
98
3550
XYZ SYSTEM
K
98
1934
THE BAGNOLI-4 EMG SYSTEM
K
98
1844
SLEEP MANAGEMENT SYSTEM
K
98
0373
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K
97
1400
MUSCLE RESPONSE MONITOR
K
97
1708
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
K
97
3537
PATHWAY ELECTROMYOGRAPH
K
97
2723
BIO TROL
K
97
2487
EMG RETRAINER
K
97
0051
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K
94
3535
MODEL ME 300 MUSCLE TESTER
K
96
3202
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K
96
5006
AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)
K
96
1645
MRS-2D
K
96
1718
DEI MODEL 20 EEG
K
96
0761
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
K
95
4737
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K
96
0762
SYNERGY PLUS
K
95
2797
AT53 DUAL CHANNEL EMG
K
92
4313
DIGITAL CONDUCTANCE METER
K
95
3257
ORALSENSOR
K
95
4127
BIOFEEDBACK DEVICE
K
95
1213
RELAXPLUS
K
94
4615
A620 EEG
K
94
5286
THE BAGNOLI-2 EMG SYSTEM
K
94
2769
BIOINTEGRATOR, BIOINTEGRATOR PLUS
K
94
5826
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K
95
1350
MUSCLESENSE ELECTROMYOGRAPHY DEVICE
K
94
1959
VERSATELL; VERSATELL-S
K
95
1969
MYOEXORCISER II FUAL
K
93
0578
AT33 EMG
K
93
0577
AT64 SCR
K
93
0576
AT42
K
94
0050
FOCUS EMG
K
92
0038
NEUROSEARCH-4
K
92
5750
RELAXOMAT
K
93
5853
EMG TRAINER
K
92
2270
PHYSIOTECH 4000 OR NORODYN 8000
K
94
1938
THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
K
91
4925
MEDAC SYSTEM/3
K
92
2838
NORODYN 2000 ELECTROMYOGRAPH
K
92
5197
PSI 220 DUAL EMG
K
91
4920
BIOFEEDBACK SYSTEM/3
K
91
5858
MYOTRAC2
K
91
5859
MYOTRAC/S, MYODAC/S
K
91
3898
MYOTRAC+/S, MYODAC+/S
K
91
1911
MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
K
91
2595
AXIOM ELECTROMYOGRAPH
K
89
7132
PATHWAY II ELECTROMYOGRAPH
K
90
5372
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
K
90
5373
MINIATURE TEMPERATURE TRAINER MODEL DT-002
K
90
3497
FLEXCOMP DSP & PROCOMP
K
90
2450
BODYLOG ENHANCED STRESS REDUCTION PACKAGE
K
89
6409
M(3):MICRO MUSCLE MONITOR
K
90
0639
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
K
89
5635
MYOSYSTEM 1000 ELECTROMYOGRAPH
K
89
5633
MYOTRACE 10 BIOFEEDBACK DEVICE
K
89
4510
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
K
89
0500
ELT OR ERGONOMIC LIFT TRAINER
K
89
2649
VERIMED MYOEXORCISER III (MYO III)
K
89
4840
MYODAC2 BIOFEEDBACK DEVICE
K
89
2114
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
K
89
1693
AUTOMATED THERAPY SYSTEM
K
88
1164
LEUNOMED RFB 5000
K
88
4849
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
K
88
4851
BIOFEEDBACK DEVICE TG3, TG4
K
88
4852
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
K
88
4850
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
K
88
4848
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
K
88
4853
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
K
88
4135
DM100 (DISTAL MONITOR - 100)
K
88
3597
MYODAC
K
88
1416
MYOTRAC
K
88
2266
DIGITAL EMG MONITOR MYOTRON 120
K
88
2062
MODEL BIOSTAR
K
88
0914
T824 TEMPERATURE MONITOR
K
88
0916
M444 EMG MONITOR
K
88
0913
M424 EMG MONITOR
K
87
3834
INET MODEL BIOVISION
K
87
5308
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
K
87
3418
BODYLOG STRESS REDUCTION PACKAGE
K
87
2495
BIOCOMP 2001 BIOFEEDBACK DEVICE
K
87
0568
BIO-PROMPT(TM)
K
87
0793
SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE
K
86
1950
THE FM-212A BIOFEEDBACK UNIT
K
86
0271
BIOFEEDBACK MICROLAB
K
85
4277
NEUROPATH 4000
K
85
2963
MYO-ACTUATOR
K
85
4208
THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS
K
85
3806
MA-400 EMB FEEDBACK DEVICE
K
85
0849
MYOMETER EMG BIOFEEDBACK DEVICE
K
85
0759
COMPUTER INTERFACE - BIOFEEDBACK
K
85
0642
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K
85
0643
HR/BVP 100T HEART RATE MONITOR
K
84
3738
CAB2 COMPUTER ASSISTED BIOFEEDBACK
K
84
3413
STRESS CONTROL BIOFEEDBACK CARD
K
84
2021
EEG BIOFEEDBACK DEVICE ACCESSORY
K
84
2023
TEMP. & GSR BIOFEEDBACK DEVICE
K
84
2022
EEG BIOFEEDBACK DEVICE
K
84
2353
TEMPERATURE 132
K
84
2288
EEG 130
K
84
1895
GSR, 126, EEG 130-TEMP. 132, EMG 133
K
84
2354
EMG MODEL 133
K
84
1128
RELAX STRESS REDUCTION SYS
K
84
0223
ORION BIOFEEDBACK DATA ACQUISITION
K
83
4110
ANTENSE ANTI-TENSION DEVICE
K
83
4111
ANTACHE ANTI-HEADACHE DEVICE
K
83
4519
CALMTONE
K
83
2714
VERIMED MYOEXORCISER
K
83
2333
FEEDBACK EMG SYSTEM PE-020
K
83
2146
TA-400 TEMP. FEEDBACK DEVICE
K
83
2122
ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED
K
82
3511
EMG BIOFEEDBACK DEVICE
K
83
0529
BIOFEEDBACK-TRAINING INSTRUMENT
K
82
3381
PROFESSIONAL MARK I BIOFEEDBACK SYS
K
82
3146
CALMSET 3 TM
K
82
2814
EMG 100T
K
81
2619
ISOLATED VOLTAGE/FREQUENCY CONVERTER
K
81
2179
LIFE-TECH #1753 BIOFEEDBACK TRAINER
K
81
0882
ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A
K
81
0881
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
K
81
0880
AR-1 PHYSIOLOGICAL PRODESSOR
K
81
0332
SC/TEMP 300
K
80
3099
BIOFEEDBACK BIO 80
K
80
2390
EMG-UT 30
K
80
2391
EMG-UT 40
K
80
1049
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
K
80
0319
ALPHA DETECTOR
K
79
2115
BIOFEEDBACK DEVICES & ACCESSORIES
K
79
2659
FEEDBACK EDR SYSTEM MODEL ME-1
K
79
1207
APOLLO HEART RATE INDICATOR
K
79
0746
THE BIONIC EXERCISER
K
78
1634
VISUALAX
K
78
0436
RELAX-A-TONE
K
77
1577
CLINICAL EMG MODEL 133
K
77
1023
ANALOG QUANTIFIER MODEL AQ-100
K
77
0787
RELAXATION COURSE MOLEL 1000
K
77
0790
FEEDBACK EDR SYSTEM MODEL EDR-100
K
77
0663
FEEDBACK EMG SYSTEM, MODEL PE-L00
K
76
1350
MYOTRON
K
77
0270
TEMPERATURE FEEDBACK SYS, MODEL DT100
K
76
0084
MONITOR, GSR (NB-401)
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
HCC
/
K992439
View Source
NORODYN 8000 SEMG SYSTEM, ND-8000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992439
510(k) Type
Special
Applicant
MYOTRONICS-NOROMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/13/1999
Days to Decision
22 days
Submission Type
Summary