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510(k) K244041

Device
Ultrasound Therapy Workstation (XMS-UET2)
Applicant
Xemis Medical Technology (Shenzhen) Co., Ltd.
510(k) number
K244041
Product code
IMG
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-07
Date received
2024-12-30
Regulation
890.5860
Classification name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yongfen Yang
Address
1101/1102/1201/1202, Unit 1, Bldg. 2, Hongpeng Bldg., Tiegang Community, Xixiang St., Baoan Shenzhen CN 518102 518102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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