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Sign in to claim this brandKoya Medical, Inc.
US
Last updated September 17, 2026
What Koya Medical, Inc. makes
Koya Medical, Inc. manufactures wearable sequential venous compression systems designed to improve venous circulation and reduce the risk of deep vein thrombosis (DVT) in patients. These devices are intended for use in clinical settings where patients require intermittent compression therapy, such as during long procedures or recovery periods.
The company’s portfolio of wearable sequential venous compression systems falls under FDA Class II regulation and is authorised through 510(k) and UDI pathways. These devices are listed in the FDA’s regulatory databases and are intended for use within the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Koya Medical, Inc. manufacture?
Koya Medical, Inc. specialises in wearable sequential venous compression systems. These devices are designed to enhance venous circulation and lower the risk of deep vein thrombosis (DVT) in patients, particularly during prolonged procedures or recovery phases. The systems are intended for clinical use where intermittent compression therapy is required.
Where is Koya Medical, Inc. based?
Koya Medical, Inc. is headquartered in the United States. The company’s focus is on developing and manufacturing medical devices authorised for use within the US market.
Which regulatory registries list Koya Medical’s devices?
Koya Medical’s wearable sequential venous compression systems are listed in the FDA’s regulatory databases under the 510(k) and Unique Device Identifier (UDI) pathways. These registries confirm the devices’ authorised status and compliance with FDA requirements.
How are Koya Medical’s devices classified by regulatory authorities?
Koya Medical’s wearable sequential venous compression systems fall under FDA Class II classification. This classification is assigned based on the devices’ intended use and associated risk levels, requiring compliance with specific regulatory controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2332 Valdina St, Dallas, TX, 75207
- Website
- koyamedical.com
- —
- —
- [email protected]
- Phone
- +1(415)209-5035
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3033981998
- DUNS Number
- 100673310
Catalogue (82)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Koya Medical | F-0100-02 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-45 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-13 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-47 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-08 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-04 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-12 | FDA UDI | Class II | Active |
| Koya Medical | F-0006-01 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-33 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-24 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-14 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-09 | FDA UDI | Class II | Active |
| Dayspring | F-0040-03 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-44 | FDA UDI | Class II | Active |
| Koya Medical | F-0010-01 | FDA UDI | Class II | Active |
| Dayspring Arm Garment | F-0010-06 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-32 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-17 | FDA UDI | Class II | Active |
| Dayspring | F-0040-01 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-07 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-21 | FDA UDI | Class II | Active |
| Dayspring | F-0040-06 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-11 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-06 | FDA UDI | Class II | Active |
| Koya Medical | F-0020-01 | FDA UDI | Class II | Active |
| Koya Medical | F-0020-04 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-40 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-29 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-15 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-22 | FDA UDI | Class II | Active |
| Dayspring | F-0040-08 | FDA UDI | Class II | Active |
| Koya Medical | F-0010-02 | FDA UDI | Class II | Active |
| Koya Medical | F-0010-03 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-37 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-26 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-05 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-34 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-35 | FDA UDI | Class II | Active |
| Koya Medical | F-0020-02 | FDA UDI | Class II | Active |
| Dayspring | F-0085-01 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-19 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-47 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-39 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-03 | FDA UDI | Class II | Active |
| Dayspring | F-0040-02 | FDA UDI | Class II | Active |
| Dayspring | F-0040-05 | FDA UDI | Class II | Active |
| Dayspring Arm Garment | F-0010-05 | FDA UDI | Class II | Active |
| Koya Medical | F-0030-04 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-30 | FDA UDI | Class II | Active |
| Koya Medical | F-0100-20 | FDA UDI | Class II | Active |
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