← Back to catalogue

RX Fit Medical Stockings

FDA 510(k)

Class II (US FDA 510(k))

510(k) K925643

by Elastic Therapy, Inc.

Identifiers

510(k) Number
K925643 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 RX Fit Medical Stockings are medical support stockings designed to prevent pooling of blood in the legs. Classified as a Class II device, these stockings apply graduated compression to improve venous circulation, reduce swelling, and help manage chronic venous insufficiency or related venous disorders.

These stockings are supplied in multiple sizes and sizes, regulated under FDA 510(k) clearance (K925643) with product code DWL. They are intended for use in general hospital settings and comply with FDA regulation 880.5780. The device is manufactured by Elastic Therapy, Inc., and includes multiple registration numbers for tracking. Usage may vary between single-use and reusable applications.

RX Fit Medical Stockings

Frequently asked questions

What are RX Fit Medical Stockings used for?

RX Fit Medical Stockings are designed to prevent pooling of blood in the legs by applying graduated compression. This helps improve venous circulation, reduce swelling, and manage chronic venous insufficiency or related venous disorders. They are particularly useful in general hospital settings for patients who may experience leg discomfort or circulation issues.

Are these stockings single-use or reusable?

The RX Fit Medical Stockings can be used for either single-use or reusable applications, depending on clinical needs and facility protocols. Reusability should be determined based on sterility, wear, and compliance with infection control guidelines to ensure patient safety and device effectiveness.

What sizes are available for RX Fit Medical Stockings?

RX Fit Medical Stockings come in multiple sizes to accommodate a range of patient needs. The exact sizing options are tailored to fit different leg measurements, ensuring proper compression and comfort. For precise sizing, refer to the manufacturer’s sizing chart or consult with a healthcare professional.

How should RX Fit Medical Stockings be stored?

RX Fit Medical Stockings should be stored in a clean, dry environment, protected from direct sunlight, moisture, and extreme temperatures. Proper storage ensures the integrity of the material and maintains the device’s compression properties. Follow manufacturer guidelines for specific storage instructions to preserve sterility and functionality.

What regulatory approvals apply to RX Fit Medical Stockings?

RX Fit Medical Stockings are classified as a Class II medical device and have received FDA 510(k) clearance under the reference number K925643. They comply with FDA regulation 880.5780 and are intended for use in general hospital settings. The device is manufactured by Elastic Therapy, Inc., and includes multiple registration numbers for tracking.

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: RX FIT MEDICAL STOCKINGS (K925643) — FDA 510 (k) | Innolitics, Elastic Therapy Inc Home | Asheboro NC, Medical Compression Products | ETI Asheboro NC - Elastic Therapy, RX FIT Trademark of Elastic Therapy, Inc. - Serial Number 74243470 - Furm

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Elastic Therapy, Inc.

Sources (1)

  • FDA 510(k) K925643 24 fields · synced Oct 1, 2026