Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim
FDA 510(k) K121059 · Zimmer Medizinsystems GmbH
510(k) numberK121059
Submission
- Device name
- Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim
- Applicant
- Zimmer Medizinsystems GmbH
Neu-Elm, DE - Received
- April 6, 2012
- Decision date
- August 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
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| 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 |
| 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 |
|---|---|---|
| K141564 | Opton ProILY · Traditional | 10/24/2014SE |
Questions and answers
When was Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim cleared by the FDA?
Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim (K121059) received a 510(k) decision of Substantially Equivalent on August 7, 2012, 123 days after the submission was received.
What is the product code of K121059?
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.