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
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
K
92
4705
FORCE SENSING ARRAY
1
Cleared 510(K)
K
92
5258
DYNAMIC PRESSURE MONITOR 2000M AND 2000C
1
Cleared 510(K)
K
92
5052
QA PRESSURE MEASUREMENT SYSTEM
1
Cleared 510(K)
K
91
5278
CDG GAIT ANALYSES SYSTEM
1
Cleared 510(K)
K
91
4776
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
1
Cleared 510(K)
K
91
3510
MECHANICAL SHAPE SENSOR
1
Cleared 510(K)
K
88
1284
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
1
Cleared 510(K)
K
88
2139
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
1
Cleared 510(K)
K
86
1260
PEDABAROGRAPH
1
Cleared 510(K)
K
83
1800
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
1
Cleared 510(K)
K
82
3681
MODEL ICPM & ACCESSORIES
1
Cleared 510(K)
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 9 May 2025 at 11:05 pm
PM
/
subpart-b—physical-medicine-diagnostic-devices
/
JFC
/
K823681
View Source
MODEL ICPM & ACCESSORIES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823681
510(k) Type
Traditional
Applicant
ELECTROMEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/1983
Days to Decision
78 days
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
IKO
Hammer, Reflex, Powered
IKP
Chronaximeter
ISB
Stimulator, Muscle, Diagnostic
JFC
System, Pressure Measurement, Intermittent
K
92
4705
FORCE SENSING ARRAY
K
92
5258
DYNAMIC PRESSURE MONITOR 2000M AND 2000C
K
92
5052
QA PRESSURE MEASUREMENT SYSTEM
K
91
5278
CDG GAIT ANALYSES SYSTEM
K
91
4776
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
K
91
3510
MECHANICAL SHAPE SENSOR
K
88
1284
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
K
88
2139
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
K
86
1260
PEDABAROGRAPH
K
83
1800
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
K
82
3681
MODEL ICPM & ACCESSORIES
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
/
JFC
/
K823681
View Source
MODEL ICPM & ACCESSORIES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823681
510(k) Type
Traditional
Applicant
ELECTROMEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/1983
Days to Decision
78 days