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Sign in to claim this brandZephyr Sleep Technologies, Inc.
US
Last updated May 27, 2026
What Zephyr Sleep Technologies, Inc. makes
Zephyr Sleep Technologies produces home-use systems for recording sleep apnoea and customisable orthotic devices to reposition the mandible for managing sleep-disordered breathing. Their portfolio includes mandibular positioners like the MATRx Plus and the TD Clip, designed for non-invasive treatment of obstructive sleep apnoea.
These devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States, adhering to applicable medical device authorisation requirements for their products.
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 Zephyr Sleep Technologies, Inc. manufacture?
Zephyr Sleep Technologies, Inc. specialises in two primary categories of medical devices: home-use sleep apnoea recording systems and mandible-repositioning orthoses for sleep-disordered breathing. Their portfolio includes devices like the MATRx Plus and TD Clip, which are designed to help manage obstructive sleep apnoea through non-invasive mandibular repositioning. These devices are intended for use in home settings, offering accessible solutions for monitoring and treatment.
Where is Zephyr Sleep Technologies, Inc. based, and how does this affect its devices?
Zephyr Sleep Technologies, Inc. is based in the United States. Since the company operates within the US regulatory framework, its devices must comply with applicable US medical device requirements, such as those outlined by the FDA. This includes adherence to classification standards, registration processes, and reporting obligations specific to the US market.
Which regulatory registries list Zephyr Sleep Technologies, Inc.’s devices?
Zephyr Sleep Technologies, Inc.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registry documents submissions demonstrating that a device is substantially equivalent to a legally marketed predicate, while the UDI system ensures traceability and identification of medical devices throughout their lifecycle. Both registries are critical for tracking and authorising device compliance in the US.
How are Zephyr Sleep Technologies, Inc.’s devices classified under US regulations?
Zephyr Sleep Technologies, Inc.’s devices are classified as Class II under the US regulatory system. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to both their sleep apnoea recording systems and mandibular repositioning orthoses, reflecting their intended use in managing sleep-disordered breathing without invasive procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zephyrsleep.com
- —
- —
- [email protected]
- Phone
- 1-877-341-8814
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 245252833
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MATRx plus | MATRx plus CAT-024-01 | FDA UDI | Class II | Active |
| TD Clip | TD Clip - Large | FDA UDI | Class II | Active |
| TD Clip | TD Clip - Medium | FDA UDI | Class II | Active |
| MATRx Plus | MATRx plus CAT-024-03 | FDA UDI | Class II | Active |
| MATRx plus | MATRx plus CAT-024-02 | FDA UDI | Class II | Active |
| Remotely controlled mandibular positioner (MATRx) | Z10-005-1.0 | FDA UDI | Class II | Active |
| MATRx plus | DEN170090 | FDA 510(k) | Class II | Active |
| MATRx Plus | K181996 | FDA 510(k) | Class II | Active |
| TD Clip | K190051 | FDA 510(k) | Class II | Active |
| MATRx plus | K200695 | FDA 510(k) | Class II | Active |
| MATRx Plus | K191925 | FDA 510(k) | Class II | Active |
| MATRx plus | K163665 | FDA 510(k) | Class II | Active |
| Remotely Controlled Mandibular Positioner, Rcmp | K103704 | FDA 510(k) | Class II | Active |
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