Compression Therapy Device LGT-2200SP
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191862 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Compression Therapy Device LGT-2200SP is a Powered Inflatable Tube Massager, designed to deliver intermittent pneumatic compression therapy. It applies controlled pressure to limbs or other body parts to improve circulation, reduce swelling, and promote recovery through sequential inflation and deflation of inflatable sleeves.
This device is used in clinical and home settings for physical medicine applications, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance and MDD compliance, with no specific sterility requirements noted. The device is classified as Class II under product code IRP, and its use is governed by regulatory standards for pneumatic compression therapy equipment. No MRI safety information or size variations are specified in the available data.
Frequently asked questions
What clinical applications is the Compression Therapy Device Model LGT-2200SP primarily used for?
The Compression Therapy Device Model LGT-2200SP is designed to deliver intermittent pneumatic compression therapy, which improves circulation, reduces swelling, and aids recovery. It is intended for use in clinical and home settings for physical medicine applications, such as treating conditions involving venous insufficiency, lymphedema, or post-surgical recovery where enhanced circulation is beneficial.
Is the Compression Therapy Device Model LGT-2200SP single-use or reusable, and what are the sterility requirements?
The Compression Therapy Device Model LGT-2200SP is supplied as a reusable medical instrument. According to the available data, there are no specific sterility requirements mentioned for this device, meaning it is not pre-sterilized for single-use and must be cleaned and maintained per manufacturer guidelines for repeated clinical use.
What regulatory pathways has the Compression Therapy Device Model LGT-2200SP followed, and how does this affect its use?
The device has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). It is classified as Class II under product code IRP, which governs its regulatory standards for pneumatic compression therapy equipment. This classification ensures it meets specific safety and performance requirements for use in clinical and home settings, but it does not imply any specific clinical indication beyond what is described in the device’s intended purpose.
Does the Compression Therapy Device Model LGT-2200SP come with multiple size options or variations for different patient needs?
The provided data does not specify any size variations or models for the Compression Therapy Device Model LGT-2200SP. It is designed as a single model for general use in intermittent pneumatic compression therapy, so compatibility with different limb sizes or body parts would depend on the included or compatible inflatable sleeves, which are not detailed in the available information.
How should the Compression Therapy Device Model LGT-2200SP be stored, and are there any special handling instructions?
The data does not explicitly outline storage instructions for the Compression Therapy Device Model LGT-2200SP. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Users should follow the manufacturer’s guidelines for maintenance and cleaning to ensure proper operation and longevity.
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. Sources consulted: Air Compression Therapy Device LGT-2200SP - GZ Longest, Compression Therapy Device Model LGT-22... (K191862) - FDA 510(k), Compression Therapy Device Model LGT-2200SP (K191862) — FDA 510(k ...
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 | K191862 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Longest Science & Technology Co., Ltd.
Sources (2)
- FDA 510(k) K191862 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026