CT2011 Sonicstimu Pain Relief Device
FDA 510(k) K092627 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK092627
Submission
- Device name
- CT2011 Sonicstimu Pain Relief Device
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, Guangdong, CN - Received
- August 26, 2009
- Decision date
- January 14, 2010
- 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 |
| 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 |
| K071137 | Sonicator Plus 940, Model ME940IMG · Abbreviated | Mettler Electronics Corp. | 08/01/2007SE |
More from Mettler Electronics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional | 06/26/2026SE |
| K240358 | ShockPhysio Mobile (model SW3200 Basic)ISA · Traditional | 06/05/2024SE |
| K213043 | Levator Elite (Model LE9011)IPF · Traditional | 02/25/2022SE |
| K210364 | Migraine Tens Digital Pain RelieverPCC · Traditional | 06/17/2021SE |
| K180331 | Wireless Pain Relieve DeviceNUH · Traditional | 06/22/2018SE |
| K171430 | Incontinence Treatment Device, Model LT2061KPI · Traditional | 03/15/2018SE |
| K173462 | Wireless Pain Relieve Device Model: LT5018CNUH · Special | 12/08/2017SE |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10IPF · Traditional | 10/02/2017SE |
| K162479 | Smart Pain Reliever, Model LT5019NUH · Traditional | 02/08/2017SE |
| K161735 | Non-contact Forehead ThermometerFLL · Traditional | 11/17/2016SE |
Questions and answers
When was CT2011 Sonicstimu Pain Relief Device cleared by the FDA?
CT2011 Sonicstimu Pain Relief Device (K092627) received a 510(k) decision of Substantially Equivalent on January 14, 2010, 141 days after the submission was received.
What is the product code of K092627?
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.