Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003857800

FEI Number

3003857800

Entity Name

IOPI MEDICAL LLC

City/State/Country

Woodinville, WA, US

Establishment Address

18500 156th Ave NE, Ste 104, Woodinville, WA 98072, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IOPI MEDICAL LLC (Owner Number: 9050864)

Owner / Operator Contact Address

18500 156th Ave NE, Ste 104, --, Woodinville, WA 98072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IOPI (Iowa Oral Performance Instrument)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKE	Transducer, Miniature Pressure	Physical Medicine	Class 1	890.1615	2016-12-20

Official Correspondent

Tara Mythen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IOPI MEDICAL LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003857800. Last updated year: 2026. Please use registration number 3003857800 when referencing this establishment in official correspondence.