GWR MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008847017	3008847017	GWR MEDICAL, INC.	1	N	2026-01-01	4 Hillman Dr Suite 106 Chadds Ford PA US 19317

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
126116	1698728676	K971507	O2 BOOT	KPJ	1997-11-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPJ	1	1997-11-07

GUDID#

O2Boot - O2Boot® – Topical Oxygen Therapy Device O2Boot® is a single-use, disposable topical oxygen therapy device intended to deliver intermittent, low-pressure oxygen directly to the wound site. GWR Medical’s Topical Oxygen (TO2) Therapy device operates at approximately 1.03 atmospheres of pressure and connects to a compatible oxygen concentrator with a single delivery port capable of providing an oxygen concentration of 85% or greater. O2Boot® is designed for use in the home by patients and in healthcare settings by medical professionals. The device is intended for application to wounds located on the legs, feet, arms, and hands.
GWR Medical, Inc.
2026-10-14
O2Sacral - O2Sacral® – Topical Oxygen Therapy Device O2Sacral® is a single-use, disposable topical oxygen therapy device intended to deliver intermittent, low-pressure oxygen directly to the wound site. GWR Medical’s Topical Oxygen (TO2) Therapy device operates at approximately 1.03 atmospheres of pressure and connects to a compatible oxygen concentrator with a single delivery port capable of providing an oxygen concentration of 85% or greater. O2Sacral® is designed for use in the home by patients and in healthcare settings by medical professionals. The device is intended for application to wounds located on the sacrum, torso, back, and thighs.
GWR Medical, Inc.
2026-10-14