510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1348
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2206
General Hospital
2053
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
473
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
280
Orthopedic
2978
Pathology
52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
398
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Jkh USA, LLC
Medical Device Manufacturer
·
US , Diamond Bar , CA
Jkh USA, LLC - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2019
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jkh USA, LLC
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 21, 2019
Medi-Direct TENS Pen
K182671
·
NUH
Neurology
·
360d
Cleared
Jun 21, 2019
JKH Stimulator Plus
K191151
·
NUH
Neurology
·
51d
Cleared
Mar 14, 2019
JKH Stimulator Plus
K182203
·
NUH
Neurology
·
211d
Filters
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9
Neurology
3
General Hospital
2
Cardiovascular
2
Physical Medicine
1
Anesthesiology
1