Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008847017

FEI Number

3008847017

Entity Name

GWR MEDICAL, INC.

City/State/Country

Chadds Ford, PA, US

Establishment Address

4 Hillman Dr Suite 106, Chadds Ford, PA 19317, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GWR Medical, Inc. (Owner Number: 10035265)

Owner / Operator Contact Address

4 Hillman Drive, Suite 106, Chadds Ford, PA 19317, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971507

PMA Number

N/A

All Registered Proprietary Names

O2Boot, O2Sacral

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2011-02-16

Official Correspondent

Sean Geary

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GWR Medical, Inc.

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 3008847017. Last updated year: 2026. Please use registration number 3008847017 when referencing this establishment in official correspondence.