Identifiers
- 510(k) Number
- K120972 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flexitouch System is a Sleeve, Limb, Compressible pneumatic compression device designed to apply sequential compression to limbs. It is intended for use in managing lymphedema and venous leg ulcers by facilitating the transport of interstitial fluid through controlled pressure cycles, improving lymphatic drainage and reducing swelling in affected areas.
This device is supplied as a reusable system with disposable sleeves, intended for use in clinical and home settings. It operates via programmable pneumatic compression, requiring connection to an external power source. The system is classified as Class II under FDA regulations (870.5800) and has received FDA 510(k) clearance (K120972) as substantially equivalent to predicate devices. Multiple sleeve sizes are available to accommodate different limb measurements, and the device must be cleaned and maintained according to manufacturer instructions.
Frequently asked questions
What is the Flexitouch System designed to treat?
The Flexitouch System is a pneumatic compression device intended for managing lymphedema and venous leg ulcers. It works by applying controlled, sequential pressure cycles to limbs, which helps facilitate the transport of interstitial fluid. This improves lymphatic drainage and reduces swelling in affected areas, supporting recovery and symptom management.
Is the Flexitouch System reusable or single-use?
The Flexitouch System itself is reusable, designed for long-term clinical and home use. However, it requires the use of disposable sleeves, which are intended for single-use to maintain hygiene and sterility between patients or applications.
What sizes are available for the Flexitouch System sleeves?
The Flexitouch System offers multiple sleeve sizes to accommodate different limb measurements. These sizes are tailored to fit various limb circumferences, ensuring proper compression and effectiveness. The exact range of sizes can be referenced in the manufacturer’s specifications or product documentation.
How should the Flexitouch System be cleaned and maintained?
The Flexitouch System must be cleaned and maintained according to the manufacturer’s instructions to ensure proper function and longevity. This typically includes regular disinfection of reusable components and proper storage to prevent contamination or damage. Follow the provided guidelines to avoid compromising performance or hygiene.
Does the Flexitouch System require a power source, and what type?
Yes, the Flexitouch System operates via programmable pneumatic compression and requires connection to an external power source. The specific power requirements, such as voltage or compatibility with medical-grade power adapters, should be confirmed in the device’s user manual or specifications.
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: Flexitouch - Tactile Medical, Upper Extremity Lymphedema Treatment - Tactile Medical, Flexitouch System (Tactile Systems Technology Inc.) for Lymphedema, Flexitouch system (Tactile Sys - INAHTA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120972 | Class II | Active |
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Manufacturer
- Manufacturer
- Tactile Systems Technology, Inc.
Sources (1)
- FDA 510(k) K120972 24 fields · synced Oct 5, 2026