Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1935459

FEI Number

1935459

Entity Name

OPOS1

City/State/Country

Waterloo, IA, US

Establishment Address

527 Park Lane, Waterloo, IA 50702, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OPOS1 (Owner Number: 10085958)

Owner / Operator Contact Address

527 Park Lane, Waterloo, IA 50702, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

outcomes system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHF	Monitor, Orthotic/Prosthetic	Physical Medicine	Class 1	890.3025	2022-09-22

Official Correspondent

Dennis Clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OPOS1

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 1935459. Last updated year: 2026. Please use registration number 1935459 when referencing this establishment in official correspondence.