510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2179
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
464
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Zhejiang Kairui Medical Device Co., Ltd.
Medical Device Manufacturer
·
CN , Ruian
Zhejiang Kairui Medical Device Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zhejiang Kairui Medical Device Co., Ltd.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 25, 2024
Electric Wheelchair (KR8803)
K241588
·
ITI
Physical Medicine
·
175d
Cleared
Nov 12, 2024
Electric wheelchair (KR-8807)
K242791
·
ITI
Physical Medicine
·
57d
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Physical Medicine
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