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LDK
Device, Sensing, Optical Contour
U
Product Code
LWB
Stimulator, Functional Neuromuscular, Scoliosis
3
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Manipulator, Plunger-Like Joint
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Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
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SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
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SEC
Wearable Fall Injury Prevention Device
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Miscellaneous
K
87
0901
MT8 BIOLOGICAL TELEMETRY SYSTEM
Cleared 510(K)
K
86
5002
A-BEC 18
Cleared 510(K)
K
86
4501
KOKEN'S NEW MODEL M-3000 POWER TABLE
Cleared 510(K)
K
86
3838
CREST CERVICAL TRACTION
Cleared 510(K)
K
86
2893
VENTRAL STANDING UNIT
Cleared 510(K)
K
86
1343
R1618, R1619 & R1654 ICE MAKING MACHINES
Cleared 510(K)
K
86
1399
POWERSTIM ELECTRONIC MUSCLE STIMULATOR
Cleared 510(K)
K
85
4194
IMT ULTRASONIC STRIDE MONITOR
Cleared 510(K)
K
86
0618
THRUST-AIRE MODEL 2001
Cleared 510(K)
K
85
3541
SP 4
Cleared 510(K)
Show All 86 Submissions
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
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Subpart F—Neurological Therapeutic Devices
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Subpart F—Physical Medicine Therapeutic Devices
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Last synced on 25 January 2026 at 3:41 am
PM
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PM-misc
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no-product-code
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K853541
View Source
SP 4
Page Type
Cleared 510(K)
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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
LDK
Device, Sensing, Optical Contour
LWB
Stimulator, Functional Neuromuscular, Scoliosis
LXM
Manipulator, Plunger-Like Joint
LZW
Monitor, Spine Curvature
MBQ
Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
MLY
Vapocoolant Device
QPY
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
QWI
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
SEC
Wearable Fall Injury Prevention Device
Submissions with No Product Code
K
87
0901
MT8 BIOLOGICAL TELEMETRY SYSTEM
K
86
5002
A-BEC 18
K
86
4501
KOKEN'S NEW MODEL M-3000 POWER TABLE
K
86
3838
CREST CERVICAL TRACTION
K
86
2893
VENTRAL STANDING UNIT
K
86
1343
R1618, R1619 & R1654 ICE MAKING MACHINES
K
86
1399
POWERSTIM ELECTRONIC MUSCLE STIMULATOR
K
85
4194
IMT ULTRASONIC STRIDE MONITOR
K
86
0618
THRUST-AIRE MODEL 2001
K
85
3541
SP 4
Show All 86 Submissions
Subpart B—Physical Medicine Diagnostic Devices
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
/
PM-misc
/
no-product-code
/
K853541
View Source
SP 4
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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