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Sign in to claim this brandSelane Products, Inc.
US
Last updated May 23, 2026
What Selane Products, Inc. makes
Selane Products, Inc. manufactures orthotic devices designed to address sleep-disordered breathing, including mandible-repositioning, tongue-training, and tongue-retaining appliances. Their portfolio also includes custom-made mouthguards tailored for specific oral and airway applications. All devices are intended for use in managing conditions related to sleep apnea and related breathing disorders.
The company’s devices are classified under FDA categories Class II and Unclassified (U), with regulatory submissions including 510(k) clearances and Unique Device Identifiers (UDIs). These products are listed in the FDA’s regulatory databases, and the manufacturer operates from 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 Selane Products, Inc. manufacture?
Selane Products, Inc. specializes in orthotic devices for managing sleep-disordered breathing. Their portfolio includes mandible-repositioning appliances, tongue-training devices, tongue-retaining appliances, and custom-made mouthguards. These devices are designed to address conditions like sleep apnea by repositioning oral structures or protecting the mouth during sleep.
Where is Selane Products, Inc. based, and how does that affect its regulatory standing?
Selane Products, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA categories such as Class II or Unclassified (U). This means their products must comply with FDA requirements for submission, clearance, and listing in databases like the 510(k) and UDI registries.
Which regulatory registries list Selane Products, Inc.’s devices, and why?
Selane Products, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. These registries are used to track and verify the regulatory status of medical devices in the U.S. The 510(k) process ensures that devices meet FDA safety and effectiveness standards before clearance, while UDIs provide a standardized way to identify devices throughout their lifecycle.
How are Selane Products, Inc.’s devices classified under FDA regulations?
Selane Products, Inc.’s devices are classified under FDA categories Class II and Unclassified (U). Class II devices generally require special controls beyond general controls to ensure safety and effectiveness, while Unclassified devices may undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a predicate device. The classification determines the regulatory pathway and submission requirements for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 066642729
Catalogue (62)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sml | 60994S | FDA UDI | Class II | Active |
| Sml | 63603NS | FDA UDI | Class II | Active |
| Sml | 63250TS | FDA UDI | Class II | Active |
| Sml | 63760AS | FDA UDI | Class II | Active |
| Sml | 63760TS | FDA UDI | Class II | Active |
| Sml | 63120S | FDA UDI | Class II | Active |
| Sml | 63760VHS | FDA UDI | Class II | Active |
| Sml | 63260S | FDA UDI | Class II | Active |
| Sml | 63603ALCS | FDA UDI | Class II | Active |
| Sml | 63400TS | FDA UDI | Class II | Active |
| Sml | 63300S | FDA UDI | Class II | Active |
| Sml | 63221S | FDA UDI | Class II | Active |
| Sml | 63120BS | FDA UDI | Class II | Active |
| Sml | 63220S | FDA UDI | Class II | Active |
| Sml | 63250S | FDA UDI | Class II | Active |
| Sml | 63252S | FDA UDI | Class II | Active |
| Sml | 63316AS | FDA UDI | Class II | Active |
| Sml | 63760TES | FDA UDI | Class II | Active |
| Sml | 63316EAS | FDA UDI | Class II | Active |
| Sml | 63603L | FDA UDI | Class II | Active |
| Sml | 63603AO2S | FDA UDI | Class II | Active |
| Sml | 63760KS | FDA UDI | Class II | Active |
| Sml | 63270S | FDA UDI | Class II | Active |
| Sml | 63210S | FDA UDI | Class II | Active |
| Sml | 63225AHS | FDA UDI | Class II | Active |
| Sml | 63760S | FDA UDI | Class II | Active |
| Sml | 63316ES | FDA UDI | Class II | Active |
| Sml | 63603AAS | FDA UDI | Class II | Active |
| Sml | 63225AS | FDA UDI | Class II | Active |
| Sml | 60994LS | FDA UDI | Class II | Active |
| Sml | 63280AS | FDA UDI | Class II | Active |
| Sml | 66030S | FDA UDI | Class II | Active |
| Sml | 63310S | FDA UDI | Class II | Active |
| Sml | 63224S | FDA UDI | Class II | Active |
| Sml | 63750S | FDA UDI | Class II | Active |
| Sml | 63603AACS | FDA UDI | Class II | Active |
| Sml | 63603LS | FDA UDI | Class II | Active |
| Sml | 63280S | FDA UDI | Class II | Active |
| Sml | 63316S | FDA UDI | Class II | Active |
| Sml | 63760HLS | FDA UDI | Class II | Active |
| Sml | 63313S | FDA UDI | Class II | Active |
| Sml | 63250AS | FDA UDI | Class II | Active |
| Sml | 63725S | FDA UDI | Class II | Active |
| Sml | 62065 | FDA UDI | U | Active |
| Sml | 63603AS | FDA UDI | Class II | Active |
| Sml | 63725AS | FDA UDI | Class II | Active |
| Sml | 63603WS | FDA UDI | Class II | Active |
| Sml | 63603PMTS | FDA UDI | Class II | Active |
| Sml | 63250SLS | FDA UDI | Class II | Active |
| Sml | 63251S | FDA UDI | Class II | Active |
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