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510(k) Data Aggregation
K Number
K223228Device Name
Dayspring
Manufacturer
Koya Medical, Inc.
Date Cleared
2024-01-04
(443 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Koya Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
- · Lymphedema
- · Primary lymphedema
- Post mastectomy edema
- · Edema following trauma and sports injuries
- · Post immobilization edema
- · Venous insufficiency
- · Reducing wound healing time
- · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
- · Lipedema
- Phlebolymphedema
Device Description
The Dayspring system consists of two main components: a controller and garment is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy the controller. A liner or lite weight clothing is worn under the garment to prevent direct patient contact with the garment is wrapped around the patient's affected area so that the device fits snugly. The device has independently controlled sections in each limb. The controller can be programmed to provide graduated sequential compression therapy to the affected area over a range of 0-100 mmHg. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility.
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K Number
K212287Device Name
Dayspring Lite
Manufacturer
Koya Medical, Inc.
Date Cleared
2021-09-21
(62 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Koya Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dayspring Lite is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision, for the following conditions:
- Chronic edema
- Lymphedema
- Venous insufficiency
- Wound healing
Dayspring Lite is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
Device Description
Dayspring Lite consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy that is activated by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment is wrapped around the patient's affected area so that the device fits snugly. The device has up to 14 independently controlled sections in each limb. The controller is pre-programmed to provide sequential compression therapy to the affected area. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility.
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K Number
K210885Device Name
Dayspring
Manufacturer
Koya Medical, Inc.
Date Cleared
2021-04-23
(29 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Koya Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
- Lymphedema
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sports injuries
- Post immobilization edema
- Venous insufficiency
- Reducing wound healing time
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
- Lipedema
- Phlebolymphedema
The Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
Device Description
The Dayspring system consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is calibrated, instantacting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment. The garment is wrapped around the patient's affected area so that the device fits snugly. The device has up to 14 independently controlled sections in each limb. The controller can be programmed to provide sequential compression therapy to the affected area over a range of 0-100 mmHg. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility.
Ask a Question
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