Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016598726

FEI Number

3016598726

Entity Name

Pure Medical Inc.

City/State/Country

Wauwatosa, WI, US

Establishment Address

10437 Innovation Drive, Suite B7, Wauwatosa, WI 53226, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Pure Medical, Inc. (Owner Number: 10062851)

Owner / Operator Contact Address

10437 Innovation Drive, Suite B7, Wauwatosa, WI 53226, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pure Day Pure Night

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-01-01

Official Correspondent

Tom Stocco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pure Medical, Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005088750	3M POLAND MANUFACTURING SP. Z O.O	WROCLAW Dolnoslaskie, PL
3013001618	CAST21 INC.	Evanston, IL, US
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3006137579	ALIGNMED INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016598726. Last updated year: 2026. Please use registration number 3016598726 when referencing this establishment in official correspondence.