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Koya Medical

FDA UDI

Class II (US FDA UDI)

by Koya Medical, Inc.

Identity

Trade Name
Koya Medical FDA UDI
Generic Name
Wearable sequential venous compression system FDA UDI
Device Name
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger FDA UDI
Model / Reference
F-0100-36 FDA UDI
Description
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger FDA UDI

Identifiers

Catalog Number
F-0100-36 FDA UDI
Primary DI / UDI-DI
00850012532460 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Wearable sequential venous compression system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wearable sequential venous compression system

Koya Medical by Koya Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable sequential venous compression system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koya Medical, Inc.

Sources (1)

  • FDA UDI c80bc50e-ad62-44e5-b233-2fa02c10995a 36 fields · synced May 29, 2026