FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
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
K
24
0632
Neuvotion NeuStim NN-01
2
Cleared 510(K)
K
23
3006
MyndMove, MyndMove 2.0
2
Cleared 510(K)
K
23
0997
EvoWalk 1.0 System
2
Cleared 510(K)
K
22
1823
Cionic Neural Sleeve NS-100
2
Cleared 510(K)
K
21
3925
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
2
Cleared 510(K)
K
21
2149
MyndMove 2.0
2
Cleared 510(K)
K
21
3622
Cionic Neural Sleeve NS-100
2
Cleared 510(K)
K
20
2110
MStim Drop Model: LGT-233
2
Cleared 510(K)
K
19
3276
Nerve and Muscle Stimulator
2
Cleared 510(K)
K
20
0262
L100 Go System
2
Cleared 510(K)
K
19
1587
L360 Thigh System
2
Cleared 510(K)
K
19
0285
L300 Go System
2
Cleared 510(K)
K
17
3682
L300 Go System
2
Cleared 510(K)
K
17
1396
ODFS Pace XL
2
Cleared 510(K)
K
16
2718
Foot Drop System (Model XFT-2001D)
2
Cleared 510(K)
K
17
0564
MyndMove System, MyndMove Functional Electrical Stimulator
2
Cleared 510(K)
K
16
2470
RT300 FES cycle ergometer
2
Cleared 510(K)
K
17
0132
MyoCycle Home, MyoCycle Pro
2
Cleared 510(K)
K
16
2683
RehaStim 2
2
Cleared 510(K)
K
16
2407
L300 Go System
2
Cleared 510(K)
K
15
3163
ReGrasp
2
Cleared 510(K)
K
14
1812
MYGAIT STIMULATION SYSTEM
2
Cleared 510(K)
K
14
0886
WALKAIDE SYSTEM
2
Cleared 510(K)
K
13
1923
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
2
Cleared 510(K)
K
13
2416
REHASTIM 2, ERIGOPRO (FES)
2
Cleared 510(K)
K
12
3636
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
2
Cleared 510(K)
K
12
3972
WALKAIDE SYSTEM
2
Cleared 510(K)
K
12
2784
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
2
Cleared 510(K)
K
12
0853
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
2
Cleared 510(K)
K
11
2844
REHASTIM 2, REHAMOVE 2
2
Cleared 510(K)
K
11
1767
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
2
Cleared 510(K)
K
10
3343
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
2
Cleared 510(K)
K
10
3370
RT200
2
Cleared 510(K)
K
10
3366
RT600
2
Cleared 510(K)
K
10
2115
ODFS PACE
2
Cleared 510(K)
K
09
0750
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
2
Cleared 510(K)
K
08
0219
MODIFICATION TO:NESS L300
2
Cleared 510(K)
K
07
3237
REHASTIM & REHAMOVE
2
Cleared 510(K)
K
07
2398
RT300-S AND RT300-SP FES CYCLE ERGOMETER
2
Cleared 510(K)
K
07
1486
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
2
Cleared 510(K)
K
07
1113
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
2
Cleared 510(K)
K
05
3468
NESS L300
2
Cleared 510(K)
K
06
0032
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
2
Cleared 510(K)
K
05
2329
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
2
Cleared 510(K)
K
05
0991
THE ODFS DROPPED FOOT STIMULATOR
2
Cleared 510(K)
K
05
0036
FES CYCLE ERGOMETER, MODEL RT300-S
2
Cleared 510(K)
K
03
1900
HANDMASTER
2
Cleared 510(K)
K
01
2823
MODIFICATION TO HANDMASTER
2
Cleared 510(K)
K
01
0837
HANDMASTER
2
Cleared 510(K)
K
97
4514
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
2
Cleared 510(K)
K
94
0759
FORTE ES
2
Cleared 510(K)
K
91
1066
COMFORTRON PT (TENS)
2
Cleared 510(K)
K
91
2615
ROCHE COBAS ARGOS 5 DIFF
2
Cleared 510(K)
K
90
3434
SELECT NEUROMUSCULAR STIMULATORS
2
Cleared 510(K)
K
87
3608
TENS LEAD
2
Cleared 510(K)
K
81
3515
VERI/DFS TM #817
2
Cleared 510(K)
K
80
0380
FES ORTHOSIS MODEL NO. 2000
2
Cleared 510(K)
K
77
0987
NERVE STIMULATOR, MOLEL NO. FB-800
2
Cleared 510(K)
K
77
0725
STIMULATOR, MUSCLE, MODEL 107
2
Cleared 510(K)
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
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 13 December 2024 at 11:05 pm
NE
/
subpart-f—neurological-therapeutic-devices
/
GZI
/
K120853
View Source
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120853
510(k) Type
Special
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/20/2012
Days to Decision
30 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
K
24
0632
Neuvotion NeuStim NN-01
K
23
3006
MyndMove, MyndMove 2.0
K
23
0997
EvoWalk 1.0 System
K
22
1823
Cionic Neural Sleeve NS-100
K
21
3925
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
K
21
2149
MyndMove 2.0
K
21
3622
Cionic Neural Sleeve NS-100
K
20
2110
MStim Drop Model: LGT-233
K
19
3276
Nerve and Muscle Stimulator
K
20
0262
L100 Go System
K
19
1587
L360 Thigh System
K
19
0285
L300 Go System
K
17
3682
L300 Go System
K
17
1396
ODFS Pace XL
K
16
2718
Foot Drop System (Model XFT-2001D)
K
17
0564
MyndMove System, MyndMove Functional Electrical Stimulator
K
16
2470
RT300 FES cycle ergometer
K
17
0132
MyoCycle Home, MyoCycle Pro
K
16
2683
RehaStim 2
K
16
2407
L300 Go System
K
15
3163
ReGrasp
K
14
1812
MYGAIT STIMULATION SYSTEM
K
14
0886
WALKAIDE SYSTEM
K
13
1923
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K
13
2416
REHASTIM 2, ERIGOPRO (FES)
K
12
3636
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
K
12
3972
WALKAIDE SYSTEM
K
12
2784
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
K
12
0853
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
K
11
2844
REHASTIM 2, REHAMOVE 2
K
11
1767
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
K
10
3343
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
K
10
3370
RT200
K
10
3366
RT600
K
10
2115
ODFS PACE
K
09
0750
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
K
08
0219
MODIFICATION TO:NESS L300
K
07
3237
REHASTIM & REHAMOVE
K
07
2398
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K
07
1486
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K
07
1113
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
K
05
3468
NESS L300
K
06
0032
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
K
05
2329
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K
05
0991
THE ODFS DROPPED FOOT STIMULATOR
K
05
0036
FES CYCLE ERGOMETER, MODEL RT300-S
K
03
1900
HANDMASTER
K
01
2823
MODIFICATION TO HANDMASTER
K
01
0837
HANDMASTER
K
97
4514
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
K
94
0759
FORTE ES
K
91
1066
COMFORTRON PT (TENS)
K
91
2615
ROCHE COBAS ARGOS 5 DIFF
K
90
3434
SELECT NEUROMUSCULAR STIMULATORS
K
87
3608
TENS LEAD
K
81
3515
VERI/DFS TM #817
K
80
0380
FES ORTHOSIS MODEL NO. 2000
K
77
0987
NERVE STIMULATOR, MOLEL NO. FB-800
K
77
0725
STIMULATOR, MUSCLE, MODEL 107
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
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
/
GZI
/
K120853
View Source
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120853
510(k) Type
Special
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/20/2012
Days to Decision
30 days
Submission Type
Summary