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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
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Miscellaneous
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
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
K
23
1575
Vecttor VT-300
2
Cleared 510(K)
K
20
2725
ETD4000
2
Cleared 510(K)
K
18
3692
Avid IF2
2
Cleared 510(K)
K
12
2944
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
2
Cleared 510(K)
K
12
1662
VECTTOR VT-200
2
Cleared 510(K)
K
11
0509
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
2
Cleared 510(K)
K
10
0246
MAX-IF1000
2
Cleared 510(K)
K
09
2780
INF 4160 PLUS, MODEL D-FJ31F
2
Cleared 510(K)
K
09
2763
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
2
Cleared 510(K)
K
09
0023
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
2
Cleared 510(K)
K
07
0890
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
2
Cleared 510(K)
K
06
0975
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
2
Cleared 510(K)
K
05
2289
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
2
Cleared 510(K)
K
04
3407
INF 4160, MODEL D-FJ27F
2
Cleared 510(K)
K
04
2057
INFINITY ELECTROTHERAPY SYSTEM
2
Cleared 510(K)
K
04
0007
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
2
Cleared 510(K)
K
04
0824
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
2
Cleared 510(K)
K
03
2719
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
2
Cleared 510(K)
K
03
3358
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
2
Cleared 510(K)
K
02
4100
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
2
Cleared 510(K)
K
02
2433
NEOGENESYS 2K
2
Cleared 510(K)
K
02
0516
CARE IFC PLUS
2
Cleared 510(K)
K
01
3082
MEDSTAR 100 INTERFERENTIAL STIMLATOR
2
Cleared 510(K)
K
00
3631
SMARTWAVE IF 2000
2
Cleared 510(K)
K
01
0948
DYNATRON STS RX
2
Cleared 510(K)
K
01
0565
DYNATRON STS
2
Cleared 510(K)
K
99
3600
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
2
Cleared 510(K)
K
99
2652
SD-730 IF-SDS, PERFECT PULSE IF-SDS
2
Cleared 510(K)
K
99
0129
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
2
Cleared 510(K)
K
97
4585
IF-727 INTERFERENTIAL STIMULATOR
2
Cleared 510(K)
K
95
2683
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
2
Cleared 510(K)
K
96
1261
DYNATRON 525
2
Cleared 510(K)
K
95
5860
MULTI III, IV
2
Cleared 510(K)
K
95
5387
ISOTRON III, ISOTRON IV
2
Cleared 510(K)
K
95
0348
DYNATRON 650
2
Cleared 510(K)
K
95
0349
DYNATRON 950
2
Cleared 510(K)
K
94
1577
DYNATRON 550
2
Cleared 510(K)
K
94
1461
DYNATRON 850
2
Cleared 510(K)
K
95
2089
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
2
Cleared 510(K)
K
94
2428
CMT-1000
2
Cleared 510(K)
K
94
1815
ISOTRON III
2
Cleared 510(K)
K
93
2868
THERATOUCH 4.7
2
Cleared 510(K)
K
93
0535
IF400
2
Cleared 510(K)
K
93
0263
MATRIX PRO-ELECDT
2
Cleared 510(K)
K
93
1732
VIFI: VECTOR INTERFERENTIAL ONE
2
Cleared 510(K)
K
93
1768
INTERFERENTIAL CURRENT THERAPY UNIT
2
Cleared 510(K)
K
93
0264
MATRIX ELECDT & VACUPULLS
2
Cleared 510(K)
K
92
5687
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
2
Cleared 510(K)
K
92
4666
INTELECT IFC2
2
Cleared 510(K)
K
92
4961
HMP 4000 INTERFERENTIAL STIMULATOR
2
Cleared 510(K)
K
92
4490
MASTERSTIM I-2
2
Cleared 510(K)
K
92
4319
DYNATRON 400
2
Cleared 510(K)
K
92
2529
POWERED MUSCLE STIMULATOR
2
Cleared 510(K)
K
92
2020
ENDOMED 582
2
Cleared 510(K)
K
91
5100
BRINDLEY & SMITH ET-1000
2
Cleared 510(K)
K
92
1491
MEDI-STIM
2
Cleared 510(K)
K
92
1954
ISOTRON III
2
Cleared 510(K)
K
92
1953
MULTI III
2
Cleared 510(K)
K
92
1612
INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2
2
Cleared 510(K)
K
92
1441
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
2
Cleared 510(K)
K
90
4743
LSI SYSTEM II
2
Cleared 510(K)
K
90
5571
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
2
Cleared 510(K)
K
88
3896
NEUROTRAIN
2
Cleared 510(K)
K
88
3462
IF-II (TM), MODEL 9800
2
Cleared 510(K)
K
88
3080
SYS*STIM 220
2
Cleared 510(K)
K
88
0924
INTER TRON 4000
2
Cleared 510(K)
K
87
0384
ENDOMED 433
2
Cleared 510(K)
K
87
3566
ELECTROSTIM I.F.
2
Cleared 510(K)
K
87
4119
INTERFERENTIAL CURRENT UNIT
2
Cleared 510(K)
K
86
1039
OMNIVAC (VACUUM ELECTRODE SYSTEM)
2
Cleared 510(K)
K
85
4721
NEMECTRODYN MODEL 2 & ENDOVAC 2
2
Cleared 510(K)
K
84
0321
ENDODYNE DUAL
2
Cleared 510(K)
K
83
3305
VECTOR SEIGE 2023645 AC POWERED STIMU-
2
Cleared 510(K)
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
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 6 December 2024 at 11:05 pm
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subpart-f—neurological-therapeutic-devices
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LIH
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K042057
View Source
INFINITY ELECTROTHERAPY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042057
510(k) Type
Traditional
Applicant
EMPI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2004
Days to Decision
140 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
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
K
23
1575
Vecttor VT-300
K
20
2725
ETD4000
K
18
3692
Avid IF2
K
12
2944
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
K
12
1662
VECTTOR VT-200
K
11
0509
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K
10
0246
MAX-IF1000
K
09
2780
INF 4160 PLUS, MODEL D-FJ31F
K
09
2763
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K
09
0023
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K
07
0890
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K
06
0975
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K
05
2289
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K
04
3407
INF 4160, MODEL D-FJ27F
K
04
2057
INFINITY ELECTROTHERAPY SYSTEM
K
04
0007
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K
04
0824
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K
03
2719
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K
03
3358
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K
02
4100
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K
02
2433
NEOGENESYS 2K
K
02
0516
CARE IFC PLUS
K
01
3082
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K
00
3631
SMARTWAVE IF 2000
K
01
0948
DYNATRON STS RX
K
01
0565
DYNATRON STS
K
99
3600
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K
99
2652
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K
99
0129
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
K
97
4585
IF-727 INTERFERENTIAL STIMULATOR
K
95
2683
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
K
96
1261
DYNATRON 525
K
95
5860
MULTI III, IV
K
95
5387
ISOTRON III, ISOTRON IV
K
95
0348
DYNATRON 650
K
95
0349
DYNATRON 950
K
94
1577
DYNATRON 550
K
94
1461
DYNATRON 850
K
95
2089
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
K
94
2428
CMT-1000
K
94
1815
ISOTRON III
K
93
2868
THERATOUCH 4.7
K
93
0535
IF400
K
93
0263
MATRIX PRO-ELECDT
K
93
1732
VIFI: VECTOR INTERFERENTIAL ONE
K
93
1768
INTERFERENTIAL CURRENT THERAPY UNIT
K
93
0264
MATRIX ELECDT & VACUPULLS
K
92
5687
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K
92
4666
INTELECT IFC2
K
92
4961
HMP 4000 INTERFERENTIAL STIMULATOR
K
92
4490
MASTERSTIM I-2
K
92
4319
DYNATRON 400
K
92
2529
POWERED MUSCLE STIMULATOR
K
92
2020
ENDOMED 582
K
91
5100
BRINDLEY & SMITH ET-1000
K
92
1491
MEDI-STIM
K
92
1954
ISOTRON III
K
92
1953
MULTI III
K
92
1612
INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2
K
92
1441
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K
90
4743
LSI SYSTEM II
K
90
5571
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
K
88
3896
NEUROTRAIN
K
88
3462
IF-II (TM), MODEL 9800
K
88
3080
SYS*STIM 220
K
88
0924
INTER TRON 4000
K
87
0384
ENDOMED 433
K
87
3566
ELECTROSTIM I.F.
K
87
4119
INTERFERENTIAL CURRENT UNIT
K
86
1039
OMNIVAC (VACUUM ELECTRODE SYSTEM)
K
85
4721
NEMECTRODYN MODEL 2 & ENDOVAC 2
K
84
0321
ENDODYNE DUAL
K
83
3305
VECTOR SEIGE 2023645 AC POWERED STIMU-
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
/
LIH
/
K042057
View Source
INFINITY ELECTROTHERAPY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042057
510(k) Type
Traditional
Applicant
EMPI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2004
Days to Decision
140 days
Submission Type
Summary