Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)— 510(k) K252154

Name: FDA 510(k) clearance K252154
Creator: U.S. Food and Drug Administration
Published: 2025-12-09

Substantially Equivalent

Guangzhou Longest Medical Technology Co., Ltd.

FDA 510(k) clearance K252154 for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP), Substantially Equivalent on 2025-12-09. Applicant: Guangzhou Longest Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Longest Medical Technology Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2025-07-09
Decision date: 2025-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.