Zeroveno
by Dimedi.co.ltd South Korea 510(k)
510(k) K192337
Product code JOW
Overview
The Zeroveno Limb Compression Sleeve is a medical device classified as a Sleeve, Limb, Compressible, designed to apply graduated compression to extremities. It is intended for use in cardiovascular applications, providing support to improve venous return and reduce swelling in the legs or arms.
This device is supplied as a single-use, non-sterile item and is intended for use in clinical settings such as hospitals or outpatient care. It is classified as a Class II device under FDA regulations (870.5800) and has received FDA 510K clearance under the Traditional pathway. Multiple sizes and reference codes are available, as listed in the OpenFDA database, ensuring compatibility with various patient limb measurements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192337 | Date22 Jun 2020 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOW
- FDA applicant
- Dimedi Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from DIMEDI.CO., Ltd.
Questions
What is the primary clinical purpose of the Zeroveno Limb Compression Sleeve and where is it typically used?
The Zeroveno Limb Compression Sleeve is designed to apply graduated compression to extremities, primarily to support cardiovascular function by improving venous return and reducing swelling in the legs or arms. It is intended for use in clinical settings such as hospitals or outpatient care, where patients may require compression therapy for conditions related to circulation.
Are the Zeroveno sleeves single-use or reusable, and what does this mean for clinical workflows?
The Zeroveno Limb Compression Sleeve is supplied as a single-use item, meaning each sleeve is intended for one-time use only. This design choice helps minimize infection risks and ensures hygiene standards are maintained in clinical workflows, particularly in settings like hospitals or outpatient care where multiple patients may be treated.
How do I determine the correct size for a patient when selecting a Zeroveno sleeve?
The Zeroveno sleeve comes in multiple sizes, as indicated by the extensive list of reference codes in the OpenFDA database. These sizes are tailored to accommodate various limb measurements, ensuring compatibility with different patient anatomies. Clinicians should refer to the manufacturer’s sizing guidelines or measurement charts to select the appropriate size for each patient’s specific limb dimensions.
Is sterility a consideration when using the Zeroveno Limb Compression Sleeve, and how should they be stored?
The Zeroveno sleeve is classified as non-sterile, so it does not require sterile handling or storage. However, it should still be stored in a clean, dry environment to maintain its integrity and usability. Proper storage conditions help preserve the material and ensure the sleeve remains effective for its intended single-use application.
What regulatory pathway was followed for FDA clearance of the Zeroveno Limb Compression Sleeve, and what does this mean for its classification?
The Zeroveno Limb Compression Sleeve received FDA 510K clearance under the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed predicate device. It is classified as a Class II device under FDA regulations (870.5800), indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K192337