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Sign in to claim this brandFRESCA MEDICAL, INC.
US
Last updated May 24, 2026
What FRESCA MEDICAL, INC. makes
The company manufactures single-use nasal masks and reusable components for continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BPAP) therapy, including nasal pillows, headgear, and tubing. It also produces home-use CPAP units and replaceable ambient air filters designed for respiratory devices.
These devices are classified as Class II under US regulatory requirements and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company is based in 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 Fresca Medical, Inc. manufacture?
Fresca Medical, Inc. specializes in devices for continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BPAP) therapy. Their product line includes single-use nasal masks, reusable components like nasal pillows, headgear, and inspiratory/expiratory tubing, as well as home-use CPAP units and replaceable ambient air filters. These devices are designed to support respiratory treatment at home.
Where is Fresca Medical, Inc. based, and how does that affect its regulatory oversight?
Fresca Medical, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulatory requirements. The FDA classifies their products as Class II, which typically requires premarket notification (510(k)) submissions and compliance with specific performance standards to ensure safety and effectiveness.
Which regulatory databases list Fresca Medical, Inc.’s devices, and why is this important?
Fresca Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database shows premarket submissions demonstrating compliance with regulatory standards, while the UDI system ensures traceability and identification of devices in clinical and commercial settings. Listing in these databases helps healthcare providers verify device authorization and track compliance.
How are Fresca Medical, Inc.’s devices classified under US regulations, and what does this mean?
Fresca Medical, Inc.’s devices are classified as Class II under US regulatory requirements. This classification indicates moderate risk and requires compliance with FDA regulations, including premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device. Class II devices also require adherence to manufacturing controls and labeling requirements to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- somnera.com
- —
- —
- [email protected]
- Phone
- 9495423535
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 068329904
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Somnera System Nasal Pillow | 60942 | FDA UDI | Class II | Active |
| Somnera Airbox Air Filter Pack | 19423 | FDA UDI | Class II | Active |
| Somnera Headgear | S1 | FDA UDI | Class II | Active |
| Somnera System Nasal Mask | 94392 | FDA UDI | Class II | Active |
| Somnera Nasal Mask | M1 (S) | FDA UDI | Class II | Active |
| Somnera Nasal Mask | M1 (L) | FDA UDI | Class II | Active |
| Somnera Backstrap | B1 | FDA UDI | Class II | Active |
| Somnera Valve | V1 | FDA UDI | Class II | Active |
| Somnera Pillow | P1 (S) | FDA UDI | Class II | Active |
| Somnera Nasal Mask Fit Kit | M3 | FDA UDI | Class II | Active |
| Somnera Hose | H1 | FDA UDI | Class II | Active |
| Somnera Nasal Pillow Fit Kit | P3 | FDA UDI | Class II | Active |
| Somnera Pillow | P1 (L) | FDA UDI | Class II | Active |
| Somnera Nasa Mask | M1 (M) | FDA UDI | Class II | Active |
| Somnera Pillow | P1 (M) | FDA UDI | Class II | Active |
| Curve Positive Airway Pressure System | DEN170089 | FDA 510(k) | Class II | Active |
| Somnera System | K200698 | FDA 510(k) | Class II | Active |
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