Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, LGT-2320SP)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252154

by Guangzhou Longest Medical Technology Co., Ltd.

Identifiers

510(k) Number: K252154 FDA 510(k)
FDA Product Code: NGX FDA 510(k)
Models / Variants: LGT-2320BE FDA 510(k)EUDAMED
LGT-2320ME FDA 510(k)EUDAMED
and LGT-2320SP FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.5850 FDA 510(k)
Regulation Number: 890.5850 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a Portable Electro Stimulation Therapy Device, classified under the Physical Medicine category. It delivers electrical stimulation to promote muscle activation, pain relief, or rehabilitation through controlled current delivery, adhering to established electrotherapy principles for therapeutic applications.

The device is supplied as a reusable medical instrument, intended for use in clinical, home, or outpatient settings. It operates with non-invasive electrodes and requires no sterilisation between uses, though proper cleaning protocols must be followed. Models include the LGT-2320BE, LGT-2320ME, and LGT-2320SP, with regulatory clearance under FDA 510K (Substantially Equivalent, K252154) and MDR. No MRI safety classification is specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K252154	Class II	Active

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Manufacturer

Manufacturer: Guangzhou Longest Medical Technology Co., Ltd.

Sources (2)

FDA 510(k) K252154 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026