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. The code's definition covers devices used for other than medical purposes that apply electrical current through skin electrodes to temporarily affect a muscle's contraction, force output, or fatigue resistance. They aren't intended for patients with medical conditions. 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
- Product 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
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