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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)
Show All 33 Submissions
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
/
K961212
View Source
SPINAL TOUCH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K961212
510(k) Type
Traditional
Applicant
FASSTECH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/1996
Days to Decision
76 days
Submission Type
Statement
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
Show All 33 Submissions
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
/
K961212
View Source
SPINAL TOUCH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K961212
510(k) Type
Traditional
Applicant
FASSTECH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/1996
Days to Decision
76 days
Submission Type
Statement