Winstim
FDA 510(k) K102190 · Johari Digital Healthcare , Ltd.
510(k) numberK102190
Submission
- Device name
- Winstim
- Applicant
- Johari Digital Healthcare , Ltd.
Jodhpur ,Rajasthan, IN - Received
- August 3, 2010
- Decision date
- March 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2)IMG · Traditional | Xemis Medical Technology (Shenzhen) Co., Ltd. | 10/07/2025SE |
| 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 |
| 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 |
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| K192039 | Torc BodyNGX · Traditional | 03/29/2020SE |
| K131291 | Torc BodyNGX · Special | 06/14/2013SE |
| K112351 | Ultra BeautyNFO · Traditional | 03/30/2012SE |
| K090052 | Cranial Electrical Nerve Stimulator, Model FM 10/CQJQ · Traditional | 05/29/2009SE |
| K062439 | Powertone, Model PT-11NGX · Traditional | 01/08/2007SE |
| K060246 | InfrexGZJ · Traditional | 05/05/2006SE |
| K024036 | Product Line-Combo Stimulator/Sequential Stimulator, Model IF-5000IPF · Special | 12/20/2002SE |
Questions and answers
When was Winstim cleared by the FDA?
Winstim (K102190) received a 510(k) decision of Substantially Equivalent on March 17, 2011, 226 days after the submission was received.
What is the product code of K102190?
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.