Enhance Support Hose
by Kimberly-Clark Corp. 510(k)
Active
510(k) K873280
Overview
The Enhance Support Hose is a medical support stocking designed to prevent pooling of blood in the legs. Classified as a Class II device under FDA regulations, it is intended for use in general hospital settings to provide graduated compression and improve venous circulation in patients at risk of venous insufficiency or thrombosis.
Supplied as a single-use item, the device is intended for application on the lower legs and is regulated under FDA 510(k) clearance (K873280). It adheres to the regulatory framework outlined in 21 CFR 880.5780 and is distributed under the product code DWL. No information regarding MRI safety or reusable applications is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873280 | Date9 Oct 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DWL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5780
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kimberly-Clark Corporation
Questions
What is the primary purpose of the Enhance Support Hose and where is it typically used?
The Enhance Support Hose is designed to prevent pooling of blood in the legs by providing graduated compression, which helps improve venous circulation. It is specifically intended for use in general hospital settings to support patients at risk of venous insufficiency or thrombosis, such as those with limited mobility or prolonged bed rest.
Is the Enhance Support Hose meant for single-use or can it be reused?
The Enhance Support Hose is explicitly supplied as a single-use item, meaning it is intended for one-time application on a patient’s lower legs. Reuse is not recommended or supported by the manufacturer’s specifications.
What regulatory pathway was followed for the FDA clearance of the Enhance Support Hose?
The Enhance Support Hose received FDA clearance through the 510(k) premarket notification process, specifically under the traditional review route with a clearance number of K873280. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device under 21 CFR 880.5780.
Are there different sizes or models available for the Enhance Support Hose?
The provided data lists multiple registration numbers and FEI numbers, which typically correspond to different sizes, styles, or variations of the device. While exact sizing details (e.g., length, circumference ranges) are not specified, the variety of registration numbers suggests the product may be available in multiple sizes to accommodate different patient leg measurements.
How should the Enhance Support Hose be stored, and is there any information about its sterility?
The Enhance Support Hose is supplied as a single-use, sterile item, though specific storage instructions (e.g., temperature, humidity, or shelf life) are not detailed in the provided data. Typically, single-use compression stockings are packaged in sterile barriers to maintain sterility until use. Always follow manufacturer guidelines for storage to ensure product integrity.