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Review Panel
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Review Panel
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Review Panel
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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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Miscellaneous
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)
K
93
1321
CSD 200/300/400/500 DYNAMOMETER
2
Cleared 510(K)
K
92
3965
NK GRASP SENSOR, MODEL GA002
2
Cleared 510(K)
K
92
3964
NK GRASP SENSOR, MODEL GA001
2
Cleared 510(K)
K
92
3963
NK DIGI-GRIP SENSOR, MODEL DGR001
2
Cleared 510(K)
K
92
3262
DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER
2
Cleared 510(K)
K
92
2029
REMUSK MP
2
Cleared 510(K)
K
92
2940
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
2
Cleared 510(K)
K
92
1268
NK DYNA-GRIP SENSOR, MODEL DG001
2
Cleared 510(K)
K
92
0183
TECH DYNE - HP-2000, SKREEN TEST, RMS-200
2
Cleared 510(K)
K
91
4436
CLINICAL HANDMASTER SYSTEM OR CHMS
2
Cleared 510(K)
K
91
4055
PINCH SENSOR, MODEL PF001
2
Cleared 510(K)
K
91
4056
NK PINCH SENSOR, MODEL PF002
2
Cleared 510(K)
K
91
4057
NK PINCH SENSOR, MODEL PA001
2
Cleared 510(K)
K
91
4054
NK GRASP SENSOR, MODEL GR001
2
Cleared 510(K)
K
91
4059
NK DEVIATION SENSOR, MODEL DV001
2
Cleared 510(K)
K
91
4058
NK PINCH SENSOR, MODEL PA002
2
Cleared 510(K)
K
91
2526
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM
2
Cleared 510(K)
K
90
1290
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
89
3537
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM
2
Cleared 510(K)
K
88
4165
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
2
Cleared 510(K)
K
88
1388
KIN-COM JR
2
Cleared 510(K)
K
88
0464
DYNATRON II
2
Cleared 510(K)
K
86
0226
FORCE EVALUATION AND TESTING SYSTEM (FETS)
2
Cleared 510(K)
K
85
0697
DIGITAL GRIP/PINCH STRENGTH METOR
2
Cleared 510(K)
K
81
2899
MED-EX
2
Cleared 510(K)
K
81
1312
MYO-METRIC II
2
Cleared 510(K)
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
/
LBB
/
K860226
View Source
FORCE EVALUATION AND TESTING SYSTEM (FETS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860226
510(k) Type
Traditional
Applicant
HOGGAN HEALTH INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/27/1986
Days to Decision
64 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
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
K
93
1321
CSD 200/300/400/500 DYNAMOMETER
K
92
3965
NK GRASP SENSOR, MODEL GA002
K
92
3964
NK GRASP SENSOR, MODEL GA001
K
92
3963
NK DIGI-GRIP SENSOR, MODEL DGR001
K
92
3262
DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER
K
92
2029
REMUSK MP
K
92
2940
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
K
92
1268
NK DYNA-GRIP SENSOR, MODEL DG001
K
92
0183
TECH DYNE - HP-2000, SKREEN TEST, RMS-200
K
91
4436
CLINICAL HANDMASTER SYSTEM OR CHMS
K
91
4055
PINCH SENSOR, MODEL PF001
K
91
4056
NK PINCH SENSOR, MODEL PF002
K
91
4057
NK PINCH SENSOR, MODEL PA001
K
91
4054
NK GRASP SENSOR, MODEL GR001
K
91
4059
NK DEVIATION SENSOR, MODEL DV001
K
91
4058
NK PINCH SENSOR, MODEL PA002
K
91
2526
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM
K
90
1290
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K
89
3537
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM
K
88
4165
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
K
88
1388
KIN-COM JR
K
88
0464
DYNATRON II
K
86
0226
FORCE EVALUATION AND TESTING SYSTEM (FETS)
K
85
0697
DIGITAL GRIP/PINCH STRENGTH METOR
K
81
2899
MED-EX
K
81
1312
MYO-METRIC II
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
/
K860226
View Source
FORCE EVALUATION AND TESTING SYSTEM (FETS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860226
510(k) Type
Traditional
Applicant
HOGGAN HEALTH INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/27/1986
Days to Decision
64 days