FDA.reportPublic FDA data

O2Sacral

Primary DI
M151O2S0020
Brand
O2Sacral
Company
GWR Medical, Inc.
Model
2
Catalog number
O2S002
Device description
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.
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KPJChamber, Oxygen, Topical, Extremity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPJChamber, Oxygen, Topical, ExtremityGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971507000O2 BOOTGwr Medical, Llp1997-11-07KPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M151O2S0020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Extremity-oxygenation hyperbaric chamber, non-poweredA small vessel intended to hermetically surround a patient's limb for the topical application of oxygen (O2) from an O2 gas supply at a pressure slightly greater than atmospheric (e.g., 1 to 2 atm) during hyperbaric oxygen therapy (HBOT). The device is typically a rigid or flexible plastic shell with valves and tubing for connection to an O2 source. It is typically used to treat skin ulcerations, decubitus ulcers, infected stumps, skin grafts, burns, and frostbite.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool dry area.

Regulatory Flags#

DUNS number
956449185
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M151O2B0020O2Boot2O2B0022026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M151O2B0020O2BootGWR Medical, Inc.KPJ2026-10-14
00850038157074VaporoxVaporox, Inc.KPJ2026-10-09
00850038157081Vaporox, Inc.Vaporox, Inc.KPJ2026-10-09
05060371000356NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
05060371000370NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
00851404004015OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004022OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004039OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004046OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004060OxyGeni® Humidicant PackElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004077OxyGeni® Dual Port cannulaElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004084OxyGeni® Electrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004091OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004107OxySpur® lite Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004114OxyGeni® Oxygen Delivery Extension SetElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004121OxySpur® lite Oxygen Diffusion DressingsElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00860010630600Numobag KitNumotech, Inc.KPJ2023-07-11
00855526003079EPIFLO®OgenixKPJ2023-06-08
00855526003086EPIFLO®OgenixKPJ2023-06-08
05060371000387NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2022-03-08
05060371000349NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000363NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000288NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000325NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000165NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000172NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000202NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000233NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000004NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05
05060371000028NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05