510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1608
Chemistry
356
Dental
1300
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1973
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2696
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
346
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Jkh Health Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Jkh Health Co., Ltd. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2016
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jkh Health Co., Ltd.
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 24, 2025
Cryon-X Cold Compression
K253150
·
IRP
Physical Medicine
·
29d
Cleared
Jun 04, 2025
Ultrasound Stimulator
K240788
·
IMI
Physical Medicine
·
439d
Cleared
May 01, 2024
Cold Compression
K240986
·
IRP
Physical Medicine
·
21d
Cleared
Oct 27, 2023
Cold/Hot Compression
K223541
·
IRP
Physical Medicine
·
336d
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10
Physical Medicine
4
Neurology
3
Cardiovascular
2
General Hospital
1