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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
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Review Panel
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Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
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Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
PDQ
Neurosurgical Nerve Locator
2
Product Code
HRW
Dynamometer, Nonpowered
1
Product Code
KQW
Goniometer, Nonpowered
1
Product Code
KQX
Goniometer, Ac-Powered
1
Product Code
K
01
1827
ORTELIUS 800
1
Cleared 510(K)
K
97
1079
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
1
Cleared 510(K)
K
96
2377
3D-SPINE
1
Cleared 510(K)
K
96
1212
SPINAL TOUCH
1
Cleared 510(K)
K
95
4647
INCLINOMETER
1
Cleared 510(K)
K
94
3929
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
1
Cleared 510(K)
K
94
5630
LARGE MUSCLE STRENGTH GAUGE
1
Cleared 510(K)
K
94
3898
SAUNDERS ELECTRONIC INCLINOMETER
1
Cleared 510(K)
K
94
0812
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
1
Cleared 510(K)
K
92
5225
THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK
1
Cleared 510(K)
K
93
3063
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
1
Cleared 510(K)
K
92
4416
BOOST, MICE, GAMESYS.
1
Cleared 510(K)
K
92
2550
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
1
Cleared 510(K)
K
92
0256
SPINE MOTION ANALYZER WITH EMG
1
Cleared 510(K)
K
92
0690
NOROTRACK 360 INCLINOMETER
1
Cleared 510(K)
K
91
4060
RANGE OF MOTION SENSOR, MODEL RM001
1
Cleared 510(K)
K
91
4062
NK DEXTERITLY BOARD, MODEL BX001
1
Cleared 510(K)
K
91
4061
NK RANGE OF MOTION SENSOR, MODEL RM002
1
Cleared 510(K)
K
91
3079
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
1
Cleared 510(K)
K
89
7178
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
1
Cleared 510(K)
K
89
4283
COMPREHENSIVE SPINE MOTION ANALYZER
1
Cleared 510(K)
K
89
3903
KRONAMAX KUBE
1
Cleared 510(K)
K
89
3455
THE HANDSCAN SYSTEM
1
Cleared 510(K)
K
88
4723
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
1
Cleared 510(K)
K
88
4611
THE ORTHORANGER II ELECTRONIC GONIOMETER
1
Cleared 510(K)
K
88
4003
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
1
Cleared 510(K)
K
87
3599
EDI 320
1
Cleared 510(K)
K
86
2128
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)
1
Cleared 510(K)
K
85
2390
CMT 1000
1
Cleared 510(K)
K
83
2991
HYPAL ADHESIVE TAPE
1
Cleared 510(K)
K
83
1040
LAMOREUX-OSI ELECTROGONIOMETER
1
Cleared 510(K)
K
81
2908
ELECTRO-GONIOMETER
1
Cleared 510(K)
K
81
0640
POLARISED LIGHT GRONIOMETER
1
Cleared 510(K)
LBB
Dynamometer, Ac-Powered
2
Product Code
NKI
Goniometer With Electrodes
2
Product Code
QWP
Optical Neurosurgical Nerve Locator
2
Product Code
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
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 16 August 2024 at 11:05 pm
NE
/
subpart-b—diagnostic-devices
/
KQX
/
K812908
View Source
ELECTRO-GONIOMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812908
510(k) Type
Traditional
Applicant
CHATTANOOGA GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/24/1981
Days to Decision
36 days
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
PDQ
Neurosurgical Nerve Locator
HRW
Dynamometer, Nonpowered
KQW
Goniometer, Nonpowered
KQX
Goniometer, Ac-Powered
K
01
1827
ORTELIUS 800
K
97
1079
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K
96
2377
3D-SPINE
K
96
1212
SPINAL TOUCH
K
95
4647
INCLINOMETER
K
94
3929
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
K
94
5630
LARGE MUSCLE STRENGTH GAUGE
K
94
3898
SAUNDERS ELECTRONIC INCLINOMETER
K
94
0812
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
K
92
5225
THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK
K
93
3063
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
K
92
4416
BOOST, MICE, GAMESYS.
K
92
2550
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
K
92
0256
SPINE MOTION ANALYZER WITH EMG
K
92
0690
NOROTRACK 360 INCLINOMETER
K
91
4060
RANGE OF MOTION SENSOR, MODEL RM001
K
91
4062
NK DEXTERITLY BOARD, MODEL BX001
K
91
4061
NK RANGE OF MOTION SENSOR, MODEL RM002
K
91
3079
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
K
89
7178
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
K
89
4283
COMPREHENSIVE SPINE MOTION ANALYZER
K
89
3903
KRONAMAX KUBE
K
89
3455
THE HANDSCAN SYSTEM
K
88
4723
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
K
88
4611
THE ORTHORANGER II ELECTRONIC GONIOMETER
K
88
4003
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
K
87
3599
EDI 320
K
86
2128
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)
K
85
2390
CMT 1000
K
83
2991
HYPAL ADHESIVE TAPE
K
83
1040
LAMOREUX-OSI ELECTROGONIOMETER
K
81
2908
ELECTRO-GONIOMETER
K
81
0640
POLARISED LIGHT GRONIOMETER
LBB
Dynamometer, Ac-Powered
NKI
Goniometer With Electrodes
QWP
Optical Neurosurgical Nerve Locator
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
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-b—diagnostic-devices
/
KQX
/
K812908
View Source
ELECTRO-GONIOMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812908
510(k) Type
Traditional
Applicant
CHATTANOOGA GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/24/1981
Days to Decision
36 days