Diacore
FDA 510(k) K253926 · ShenB Co., Ltd.
510(k) numberK253926
Submission
- Device name
- Diacore
- Applicant
- ShenB Co., Ltd.
Seoul, KR - Received
- December 8, 2025
- Decision date
- April 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
Other 510(k)s with product code NGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253636 | Zionic Pro Max (EMS)NGX · Traditional | Termosalud S.L. | 03/12/2026SE |
| K253408 | CoolToneNGX · Traditional | Zimmer Medizinsysteme GmbH | 01/16/2026SE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)NGX · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 12/09/2025SE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003)NGX · Traditional | Motive Health, Inc. | 11/06/2025SE |
| K251594 | truFlexNGX · Special | Syrma Johari Medtech Limited | 08/28/2025SE |
| K251706 | TENS and EMS UnitNGX · Special | Changsha Anxiang Medical Technology Co., Ltd. | 07/30/2025SE |
| K251378 | CoolToneNGX · Special | Zimmer Medizinsysteme GmbH | 07/14/2025SE |
| K251746 | Pure ImpactNGX · Special | Sofwave Medical, Ltd. | 07/02/2025SE |
| K250759 | 3 in 1 TENS UNITNGX · Traditional | Changsha Anxiang Medical Technology Co., Ltd. | 06/13/2025SE |
More from Changsha Anxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251649 | Sunny Plus (Sunny)NFO · Traditional | 09/18/2025SE |
| K242241 | SunnyGEI · Traditional | 03/19/2025SE |
| K241535 | Vybe RF IIGEI · Traditional | 09/25/2024SE |
| K232223 | PlaDuo SystemGEI · Traditional | 10/24/2023SE |
| K230968 | VYBE RF Electrosurgical SystemGEI · Special | 07/06/2023SE |
| K221363 | AF LaserPDZ · Traditional | 07/20/2022SE |
| K211562 | Virtue RFGEI · Traditional | 11/23/2021SE |
| K193070 | VIVACE Electrosurgical DeviceGEI · Traditional | 04/26/2021SE |
| K202415 | VirtueRFGEI · Traditional | 01/22/2021SE |
| K201735 | PlaDuo SystemGEI · Traditional | 12/14/2020SE |
Questions and answers
When was Diacore cleared by the FDA?
Diacore (K253926) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 123 days after the submission was received.
What is the product code of K253926?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.