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Miscellaneous
ESI
Polymer, Natural-Absorbable Gelatin Material
3
Product Code
EWD
Protector, Hearing (Insert)
U
Product Code
EWE
Protector, Hearing (Circumaural)
U
Product Code
LEZ
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
U
Product Code
LFA
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
U
Product Code
LFB
Button, Nasal Septal
U
Product Code
LRA
Hearing Aid, Tactile
U
Product Code
LXV
Apparatus, Vestibular Analysis
U
Product Code
K
22
0231
GyroStim
U
Cleared 510(K)
K
20
0529
Orion
U
Cleared 510(K)
K
19
2652
TRV
U
Cleared 510(K)
K
18
3661
ClearEdge Balance System
U
Cleared 510(K)
K
19
0735
EQ Balance
U
Cleared 510(K)
K
17
3669
K-D Balance
U
Cleared 510(K)
K
12
1590
VESTIBULAR ANALYSIS APPARATUS
U
Cleared 510(K)
K
10
2364
NYDIAG 200
U
Cleared 510(K)
K
08
2634
VERTIGONE BPPV GOGGLE
U
Cleared 510(K)
K
08
1602
DIZZYFIX
U
Cleared 510(K)
K
07
1973
EPLEY OMNIAX
U
Cleared 510(K)
K
07
0676
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
U
Cleared 510(K)
K
07
0085
BALANCE REHABILITATION UNIT (BRU)
U
Cleared 510(K)
K
97
1549
VMT SYSTEM
U
Cleared 510(K)
K
92
2037
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
U
Cleared 510(K)
K
91
1795
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
U
Cleared 510(K)
K
89
1008
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
U
Cleared 510(K)
K
88
4926
BALANCE SYSTEM
U
Cleared 510(K)
K
87
2093
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
U
Cleared 510(K)
K
85
1744
EQUITEST
U
Cleared 510(K)
K
78
1268
CHAIR, VESTIBULAR, ROTARY, COMPUT.
U
Cleared 510(K)
K
77
1618
COMPUTERIZED POSTURE PLATFORM
U
Cleared 510(K)
MCM
Implant, Cochlear
3
Product Code
MHE
Implant, Auditory Brainstem
3
Product Code
MJV
Device, Inflation, Middle Ear
U
Product Code
MPV
Implant, Hearing, Active, Middle Ear, Partially Implanted
3
Product Code
MRK
System, Imaging, Fluorescence
3
Product Code
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
2
Product Code
OAA
Aid, Visual, For Nausea
N
Product Code
QLV
Field Generator Positioning Device
1
Product Code
EPG
Stimulator, Transdermal
3
Product Code
OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
3
Product Code
OAQ
Electronic Media, Hyperacusis
N
Product Code
OWO
Drug-Eluting Sinus Stent
3
Product Code
PGQ
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
3
Product Code
QJA
Tympanostomy Tube Delivery Product With Drug
3
Product Code
QOO
Ventilator Tubing And Accessories
N
Product Code
QOP
Respiratory Humidifier For Emergency Use
N
Product Code
QOS
Continuous Ventilator
N
Product Code
QOT
Emergency Ventilator
N
Product Code
QOV
Critical Care Ventilator
N
Product Code
QOX
Multi-Patient Circuit Connector
N
Product Code
QQG
Oropharyngeal Electrical Stimulator
2
Product Code
QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
2
Product Code
QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
2
Product Code
QZC
External Mechanical Stimulator For The Relief Of Congestion
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
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Hematology
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Immunology
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Microbiology
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Neurology
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Obstetrical and Gynecological
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Orthopedic
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General and Plastic Surgery
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Medical Genetics
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Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
EN
/
EN-misc
/
LXV
/
K070085
View Source
BALANCE REHABILITATION UNIT (BRU)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K070085
510(k) Type
Traditional
Applicant
MEDICAA (URUGUAY) S.A.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/26/2007
Days to Decision
48 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
ESI
Polymer, Natural-Absorbable Gelatin Material
EWD
Protector, Hearing (Insert)
EWE
Protector, Hearing (Circumaural)
LEZ
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
LFA
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
LFB
Button, Nasal Septal
LRA
Hearing Aid, Tactile
LXV
Apparatus, Vestibular Analysis
K
22
0231
GyroStim
K
20
0529
Orion
K
19
2652
TRV
K
18
3661
ClearEdge Balance System
K
19
0735
EQ Balance
K
17
3669
K-D Balance
K
12
1590
VESTIBULAR ANALYSIS APPARATUS
K
10
2364
NYDIAG 200
K
08
2634
VERTIGONE BPPV GOGGLE
K
08
1602
DIZZYFIX
K
07
1973
EPLEY OMNIAX
K
07
0676
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
K
07
0085
BALANCE REHABILITATION UNIT (BRU)
K
97
1549
VMT SYSTEM
K
92
2037
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
K
91
1795
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
K
89
1008
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
K
88
4926
BALANCE SYSTEM
K
87
2093
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
K
85
1744
EQUITEST
K
78
1268
CHAIR, VESTIBULAR, ROTARY, COMPUT.
K
77
1618
COMPUTERIZED POSTURE PLATFORM
MCM
Implant, Cochlear
MHE
Implant, Auditory Brainstem
MJV
Device, Inflation, Middle Ear
MPV
Implant, Hearing, Active, Middle Ear, Partially Implanted
MRK
System, Imaging, Fluorescence
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
OAA
Aid, Visual, For Nausea
QLV
Field Generator Positioning Device
EPG
Stimulator, Transdermal
OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
OAQ
Electronic Media, Hyperacusis
OWO
Drug-Eluting Sinus Stent
PGQ
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
QJA
Tympanostomy Tube Delivery Product With Drug
QOO
Ventilator Tubing And Accessories
QOP
Respiratory Humidifier For Emergency Use
QOS
Continuous Ventilator
QOT
Emergency Ventilator
QOV
Critical Care Ventilator
QOX
Multi-Patient Circuit Connector
QQG
Oropharyngeal Electrical Stimulator
QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
QZC
External Mechanical Stimulator For The Relief Of Congestion
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
EN-misc
/
LXV
/
K070085
View Source
BALANCE REHABILITATION UNIT (BRU)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K070085
510(k) Type
Traditional
Applicant
MEDICAA (URUGUAY) S.A.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/26/2007
Days to Decision
48 days
Submission Type
Summary