Portable Electro-Stimulation Therapy Device LGT-232(US)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201845 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
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)
The Portable Electro-Stimulation Therapy Device LGT-232(US) is a physical medicine device designed to deliver electrostimulation therapy. It is classified under the Physical Medicine category and is intended for use in controlled therapeutic applications to stimulate muscles or nerves for rehabilitation purposes.
This device is supplied as a portable unit and is cleared under the FDA’s 510(k) pathway as substantially equivalent to existing devices. It is not specified as single-use or reusable, and no details on sterility or MRI safety are provided. The device is manufactured by Guangzhou Longest Science & Technology Co., Ltd., and its regulatory status includes FDA 510K clearance and compliance with the Medical Device Directive (MDD).
Frequently asked questions
What specific therapeutic applications is this electro-stimulation device intended for in clinical settings?
The Portable Electro-Stimulation Therapy Device (Model LGT-232(US)) is designed for controlled therapeutic applications to stimulate muscles or nerves as part of rehabilitation. It falls under the Physical Medicine category, meaning it is intended for use in physical therapy or recovery programs where electrical stimulation aids in muscle activation, nerve regeneration, or pain management. Always follow clinical guidelines and consult with a healthcare provider to determine appropriate use.
How is this device supplied, and what should I consider regarding its portability?
The LGT-232(US) is explicitly described as a portable unit, meaning it is designed for easy transport and use in various clinical or home settings. While the exact packaging details (e.g., included accessories, cables, or electrodes) aren’t specified, its portability suggests it may be compact and battery-powered or plug-and-play for flexibility. Verify compatibility with your facility’s infrastructure (e.g., power sources) before use.
Is this device single-use or reusable, and what are the implications for cleaning or sterilization?
The provided data does not specify whether the LGT-232(US) is single-use or reusable. If reusable, proper cleaning and sterilization protocols (e.g., disinfection of electrodes or probes) would be required to prevent cross-contamination. If single-use, check the packaging for disposal instructions. Always adhere to manufacturer guidelines or facility policies to ensure safe and compliant use.
What regulatory pathways has this device undergone, and how does that affect its use in clinical practice?
The LGT-232(US) has been cleared via the FDA’s 510(k) pathway, specifically under the Physical Medicine category, with a decision of *Substantially Equivalent* to existing devices. It also complies with the Medical Device Directive (MDD). This means it meets FDA standards for safety and effectiveness as determined by a review of its equivalence to predicate devices. Clinicians can rely on this clearance for its intended use in electrostimulation therapy, though local facility protocols may still apply.
Are there any known limitations or considerations regarding the device’s use in environments with MRI machines?
The data does not provide explicit information about the LGT-232(US)’s MRI safety (e.g., whether it is MRI-conditional, MRI-safe, or contraindicated). If used near MRI equipment, ensure the device does not contain metallic components or electronic interference risks. Always verify compatibility with your facility’s MRI safety guidelines or consult the manufacturer for specific warnings before use in such environments.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201845 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Longest Science & Technology Co., Ltd.
Sources (2)
- FDA 510(k) K201845 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026