Ultrasound Therapy Workstation (XMS-UET2)
FDA 510(k) K244041 · Xemis Medical Technology (Shenzhen) Co., Ltd.
510(k) numberK244041
Submission
- Device name
- Ultrasound Therapy Workstation (XMS-UET2)
- Applicant
- Xemis Medical Technology (Shenzhen) Co., Ltd.
Shenzhen, CN - Received
- December 30, 2024
- Decision date
- October 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMG – Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5860
- Specialty
- Physical Medicine
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|---|---|---|---|
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemIMG · Traditional | Accelerated Care Plus (Acp) | 08/26/2016SE |
| K150436 | ComboRehabIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 11/13/2015SE |
| K150353 | BTL-4000IMG · Traditional | BTL Industries, Inc. | 11/13/2015SE |
| K120217 | Sonicstimu Combo Therapeutic DeviceIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 11/21/2012SE |
| K121059 | Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimIMG · Abbreviated | Zimmer Medizinsystems GmbH | 08/07/2012SE |
| K102524 | FuturaIMG · Traditional | Dr. Oliver Wenker, M.D., M.B.A. | 11/03/2011SE |
| K111482 | Sonicator Plus 920IMG · Special | Mettler Electronics Corp. | 08/25/2011SE |
| K102190 | WinstimIMG · Special | Johari Digital Healthcare , Ltd. | 03/17/2011SE |
| K092627 | CT2011 Sonicstimu Pain Relief DeviceIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 01/14/2010SE |
| K071137 | Sonicator Plus 940, Model ME940IMG · Abbreviated | Mettler Electronics Corp. | 08/01/2007SE |
More from Mettler Electronics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243993 | Photon Therapy Apparatus (BL-10)GEX · Traditional | 03/13/2025SE |
Questions and answers
When was Ultrasound Therapy Workstation (XMS-UET2) cleared by the FDA?
Ultrasound Therapy Workstation (XMS-UET2) (K244041) received a 510(k) decision of Substantially Equivalent on October 7, 2025, 281 days after the submission was received.
What is the product code of K244041?
The FDA product code is IMG – Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5860.