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FDA 510(k)

Ultrasound Therapy Workstation (XMS-UET2)

K-Number: K244041 · 2025-10-07

ApplicantXemis Medical Technology (Shenzhen) Co., Ltd.
Decision Date2025-10-07
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ultrasound Therapy Workstation (XMS-UET2) is a medical device manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-10-07 under approval number K244041. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound Therapy Workstation (XMS-UET2)?

Ultrasound Therapy Workstation (XMS-UET2) is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K244041.

When was Ultrasound Therapy Workstation (XMS-UET2) approved by the FDA?

Ultrasound Therapy Workstation (XMS-UET2) received FDA 510(k) clearance on 2025-10-07, under approval number K244041.

What company makes Ultrasound Therapy Workstation (XMS-UET2)?

Ultrasound Therapy Workstation (XMS-UET2) is manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd..

What is the FDA product code for Ultrasound Therapy Workstation (XMS-UET2)?

The FDA product code for Ultrasound Therapy Workstation (XMS-UET2) is IMG.

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Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025)

Other Devices by Xemis Medical Technology (Shenzhen) Co., Ltd.

K243993Photon Therapy Apparatus (BL-10)

Related Devices (Code: IMG)

K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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