Diacore— 510(k) K253926
Substantially EquivalentShenB Co., Ltd.
FDA 510(k) clearance K253926 for Diacore, Substantially Equivalent on 2026-04-10. Applicant: ShenB Co., Ltd.. Device class: 2.
Summary
Diacore is filed under NGX, powered muscle stimulators for muscle conditioning. These deliver electrical or electromagnetic stimulation to make muscles contract, and the code is widely used for toning and body contouring products. Pain relief TENS units sit under different codes. The record doesn't describe Diacore further.
Class II, 21 CFR 890.5850. The Physical Medicine panel reviewed it as a Traditional 510(k).
ShenB Co. filed from Seoul, South Korea. Review took 123 days (December 8, 2025 to April 10, 2026).
Clearance details
- Applicant
- ShenB Co., Ltd.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code NGX
view allMore clearances from ShenB Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.