FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
IKD
Cable, Electrode
2
Product Code
IKE
Transducer, Miniature Pressure
1
Product Code
IKK
System, Isokinetic Testing And Evaluation
2
Product Code
K
12
3746
AMES THERAPY DEVICE
2
Cleared 510(K)
K
95
2090
HUMAC SYSTEM
2
Cleared 510(K)
K
95
1770
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
2
Cleared 510(K)
K
95
1916
CC RIDER, MODEL ME180
2
Cleared 510(K)
K
95
0095
CYBEX 770
2
Cleared 510(K)
K
94
2229
MOTIVATOR FTR 2000
2
Cleared 510(K)
K
94
4732
DEXTER ISOKINETIC
2
Cleared 510(K)
K
92
4414
THE BTE DYNAMIC LIFT
2
Cleared 510(K)
K
92
3350
CLOSED CHAIN ATTACHMENT, MODEL #820-520
2
Cleared 510(K)
K
92
2772
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
2
Cleared 510(K)
Show All 61 Submissions
IKO
Hammer, Reflex, Powered
2
Product Code
IKP
Chronaximeter
2
Product Code
ISB
Stimulator, Muscle, Diagnostic
2
Product Code
JFC
System, Pressure Measurement, Intermittent
1
Product Code
KHX
Platform, Force-Measuring
1
Product Code
OAL
Exercise Equipment, Powered, Emg-Triggered
2
Product Code
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
PM
/
subpart-b—physical-medicine-diagnostic-devices
/
IKK
/
K123746
View Source
AMES THERAPY DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123746
510(k) Type
Traditional
Applicant
AMES TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2013
Days to Decision
169 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
IKD
Cable, Electrode
IKE
Transducer, Miniature Pressure
IKK
System, Isokinetic Testing And Evaluation
K
12
3746
AMES THERAPY DEVICE
K
95
2090
HUMAC SYSTEM
K
95
1770
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
K
95
1916
CC RIDER, MODEL ME180
K
95
0095
CYBEX 770
K
94
2229
MOTIVATOR FTR 2000
K
94
4732
DEXTER ISOKINETIC
K
92
4414
THE BTE DYNAMIC LIFT
K
92
3350
CLOSED CHAIN ATTACHMENT, MODEL #820-520
K
92
2772
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
Show All 61 Submissions
IKO
Hammer, Reflex, Powered
IKP
Chronaximeter
ISB
Stimulator, Muscle, Diagnostic
JFC
System, Pressure Measurement, Intermittent
KHX
Platform, Force-Measuring
OAL
Exercise Equipment, Powered, Emg-Triggered
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
/
subpart-b—physical-medicine-diagnostic-devices
/
IKK
/
K123746
View Source
AMES THERAPY DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123746
510(k) Type
Traditional
Applicant
AMES TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2013
Days to Decision
169 days
Submission Type
Summary