Futura
FDA 510(k) K102524 · Dr. Oliver Wenker, M.D., M.B.A.
510(k) numberK102524
Submission
- Device name
- Futura
- Applicant
- Dr. Oliver Wenker, M.D., M.B.A.
Farmers Branch, TX, US - Received
- September 2, 2010
- Decision date
- November 3, 2011
- 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
Other 510(k)s with product code IMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Futura cleared by the FDA?
Futura (K102524) received a 510(k) decision of Substantially Equivalent on November 3, 2011, 427 days after the submission was received.
What is the product code of K102524?
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.