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Marlene Stockings & Tights

FDA 510(k)

Class II (US FDA 510(k))

510(k) K954295

by Professional Products, Inc.

Identifiers

510(k) Number
K954295 FDA 510(k)
FDA Product Code
DWL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5780 FDA 510(k)
Regulation Number
880.5780 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Marlene Stockings and Tights are classified as Medical Support Stockings, designed to prevent pooling of blood in the legs. These devices are intended for use in general hospital settings to aid venous circulation and reduce the risk of complications such as deep vein thrombosis (DVT) or edema in patients who are immobile or at risk for circulatory issues.

These stockings and tights are supplied in various sizes and are intended for single-use or reusable applications, depending on the specific model and material. They are regulated under FDA 510(k) clearance (K954295) and fall under Device Class II (DWL). The products are intended for sterile use and must be handled according to medical facility protocols. No MRI safety information is provided, and storage conditions should follow manufacturer guidelines to maintain integrity.

Frequently asked questions

Are these stockings and tights intended for use in specific patient populations, and how do they help?

The Marlene Stockings and Tights are designed for general hospital use to assist patients who are immobile or at risk for circulatory issues. They help prevent pooling of blood in the legs, which can reduce the risk of complications like deep vein thrombosis (DVT) or edema by aiding venous circulation.

How are these stockings and tights supplied, and what should I consider regarding their use?

These stockings and tights come in various sizes and are available for either single-use or reusable applications, depending on the specific model and material. Since they are intended for sterile use, they must be handled according to your facility’s medical protocols to maintain sterility and integrity.

Are these stockings and tights reusable, and if so, what factors determine their reuse eligibility?

The Marlene Stockings and Tights can be either single-use or reusable, depending on the model and material. Reuse eligibility is determined by the specific product variant, so always refer to the manufacturer’s guidelines or packaging instructions to confirm whether a particular pair is intended for reuse or single-use.

What storage conditions should be followed to ensure the stockings and tights remain effective?

Storage conditions for the Marlene Stockings and Tights should follow the manufacturer’s guidelines to preserve their integrity. While specific storage instructions aren’t detailed in the data, adhering to standard medical device storage protocols—such as protecting from moisture, extreme temperatures, and contamination—is recommended to maintain their performance.

What regulatory pathway was followed for FDA clearance of these stockings and tights?

The Marlene Stockings and Tights were cleared through the FDA’s 510(k) process, specifically under the traditional review pathway, and are classified as Device Class II under the product code DWL. The clearance number is K954295, and the submission was filed in 1995 with a decision date of November 8, 1995.

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: MARLENE STOCKINGS & TIGHTS (K954295) — FDA 510(k) | Innolitics, Marlene Stockings & Tights 510 (k) FDA Premarket Notification K954295 ..., About Us — Professional Products, Inc., FAQs — Professional Products, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Professional Products, Inc.

Sources (1)

  • FDA 510(k) K954295 24 fields · synced Sep 20, 2026