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Dayspring

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223228

by Koya Medical, Inc.

Identifiers

510(k) Number
K223228 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 Dayspring Active Compression System is a wearable, non-pneumatic device classified as a Sleeve, Limb, Compressible (OpenFDA: JOW). It is designed to provide active dynamic compression for the treatment of lymphedema and chronic edema by stimulating lymphatic flow in the limbs. The system applies sequential, programmable compression to support mobility and enhance fluid circulation during daily activities.

This device is intended for single-use or reusable applications, depending on the sleeve size and model, and is regulated under FDA 510(k) clearance (K223228) as a Class II medical device (regulation number 870.5800). Available in multiple sizes for both upper and lower extremities, the system is designed for use in clinical and home settings. Compatibility with MRI environments is not specified in the data provided.

Frequently asked questions

What is the primary purpose of the Dayspring Active Compression System, and how does it differ from traditional compression sleeves?

The Dayspring Active Compression System is designed to provide active dynamic compression for managing lymphedema and chronic edema by stimulating lymphatic flow in the limbs. Unlike traditional static compression sleeves, it applies sequential, programmable compression to support mobility and enhance fluid circulation during daily activities, making it suitable for both clinical and home use.

Can the Dayspring system be reused, or is it intended for single-use only?

The Dayspring system is not exclusively single-use or reusable—its reuse depends on the specific sleeve size and model. The manufacturer offers options for both single-use and reusable applications, allowing flexibility based on clinical or patient needs. Always check the labeling or consult the manufacturer for guidance on a particular sleeve’s intended use.

What limb sizes and types does the Dayspring system accommodate, and how do I determine the correct fit?

The Dayspring system is available in multiple sizes for both upper and lower extremities, covering a range of limb measurements. The exact sizing options are listed in the provided OpenFDA registration numbers (e.g., 3000143502, 3004105270), which correspond to specific models. To determine the correct fit, refer to the manufacturer’s sizing charts or consult a healthcare professional familiar with the device’s dimensions.

Is the Dayspring system compatible with MRI environments, and if not, what precautions should be taken?

The provided data does not specify MRI compatibility for the Dayspring system. If MRI use is required, consult the manufacturer (Koya Medical, Inc.) for guidance or verify compatibility with the specific model in question. Until confirmed, avoid using the device in MRI environments unless explicitly approved for such use.

How was the Dayspring Active Compression System regulated by the FDA, and what does this mean for its clinical use?

The Dayspring system received FDA 510(k) clearance (K223228) under the classification of a Class II medical device (regulation number 870.5800), meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates it meets FDA safety and effectiveness requirements for its intended use—active dynamic compression for lymphedema and chronic edema—but does not imply universal clinical suitability without professional evaluation.

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: Dayspring Treatment for Lymphedema | Koya Medical, Koya Medical | Lymphatic Education & Research Network, Koya Dayspring Therapy - The Compression Closet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Koya Medical, Inc.

Sources (1)

  • FDA 510(k) K223228 24 fields · synced Sep 20, 2026