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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
LBB
Dynamometer, Ac-Powered
2
Product Code
K
16
2412
Hoggan Scientific® microFET2™
2
Cleared 510(K)
K
07
3154
FACTS HAND AND PINCH GRIP COMBO
2
Cleared 510(K)
K
05
2309
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
2
Cleared 510(K)
K
04
2889
DYNAMOMETER - MODEL FCE AND MODEL MSC
2
Cleared 510(K)
K
01
2492
KADANCE 2000
2
Cleared 510(K)
K
98
1730
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
2
Cleared 510(K)
K
98
0363
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
2
Cleared 510(K)
K
96
4933
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
2
Cleared 510(K)
K
96
4685
DYNAMOMETER
2
Cleared 510(K)
K
93
5757
GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
2
Cleared 510(K)
Show All 36 Submissions
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 20 December 2024 at 11:05 pm
NE
/
subpart-b—diagnostic-devices
/
LBB
/
K012492
View Source
KADANCE 2000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012492
510(k) Type
Traditional
Applicant
KADA RESEARCH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2001
Days to Decision
91 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
PDQ
Neurosurgical Nerve Locator
HRW
Dynamometer, Nonpowered
KQW
Goniometer, Nonpowered
KQX
Goniometer, Ac-Powered
LBB
Dynamometer, Ac-Powered
K
16
2412
Hoggan Scientific® microFET2™
K
07
3154
FACTS HAND AND PINCH GRIP COMBO
K
05
2309
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
K
04
2889
DYNAMOMETER - MODEL FCE AND MODEL MSC
K
01
2492
KADANCE 2000
K
98
1730
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K
98
0363
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K
96
4933
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K
96
4685
DYNAMOMETER
K
93
5757
GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
Show All 36 Submissions
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
/
LBB
/
K012492
View Source
KADANCE 2000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012492
510(k) Type
Traditional
Applicant
KADA RESEARCH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2001
Days to Decision
91 days
Submission Type
Summary