WHEATON BRACE COMPANY

FDA Device Registration & Listing · Carol Stream, IL, US · Registration 3015194285

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015194285
FEI Number
3015194285
Entity Name
WHEATON BRACE COMPANY
City/State/Country
Carol Stream, IL, US
Establishment Address
387 S. SCHMALE ROAD, Carol Stream, IL 60188, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Wheaton Brace Company (Owner Number: 10059287)
Owner / Operator Contact Address
387 S. SCHMALE ROAD, Carol Stream, IL 60188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pediatric Knee Immobilizer Wheaton Pavlik Harness Wheaton Hip Abduction Orthosis Wheaton AFO Wheaton KAFO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIL Positioner, Socket Orthopedic Class 1 888.4540 2023-01-05
IOZ Splint, Abduction, Congenital Hip Dislocation Physical Medicine Class 1 890.3665 2018-12-18
LGF Component, Cast Orthopedic Class 1 888.5940 2023-01-05

Official Correspondent

Pauline Kee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wheaton Brace Company
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 3015194285. Last updated year: 2026. Please use registration number 3015194285 when referencing this establishment in official correspondence.
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