Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017791238

FEI Number

3017791238

Entity Name

Somnics Health

City/State/Country

Redwood City, CA, US

Establishment Address

370 Convention way, Redwood City, CA 94063, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Somnics, Inc. (Owner Number: 10058120)

Owner / Operator Contact Address

5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,, Zhubei City, TW-HSQ 30261, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193460

PMA Number

N/A

All Registered Proprietary Names

The iNAP One Sleep Therapy System ZeeBud ZEEPAP iNAP One Sleep Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZR	Intraoral Pressure Gradient Device	Dental	Class 2	872.5570	2024-01-03
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2022-04-08
OZR	Intraoral Pressure Gradient Device	Dental	Class 2	872.5570	2020-05-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Somnics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014674517	SOMNICS, INC.	Zhubei City Hsinchu, TW

Similar Registrations

Registration Number	Establishment Name	Location
3014674517	SOMNICS, INC.	Zhubei City Hsinchu, TW
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3009227226	AIRMAX B.V.	Oegstgeest Zuid-Holland, NL
3011956575	G & G PRODUCTS, LLC	Kennebunk, ME, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017791238. Last updated year: 2026. Please use registration number 3017791238 when referencing this establishment in official correspondence.