FDA.reportPublic FDA data

HMS-2000

Primary DI
00860006478940
Brand
HMS-2000
Company
Hyperbaric Modular Systems Inc.
Model
HMS-2000
Device description
The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011866000OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIESHyperbaric Technologies, Inc.2002-06-06CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006478940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006478940008600064789408600064789400860006478940

GMDN Terms#

Term, Definition table
TermDefinition
Hyperbaric chamber, stationaryA mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831644005
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006478988HMS-5000-6-MINI-QUADROHMS-5000-62026-05-05
00860006478919HMS-5000HMS-5000-12-COMPACT-QUADRO2025-06-16
00860006478964HMS-1000HMS-10002023-08-02
00860006478926HMS-4000HMS-40002023-08-01
00860006478902HMS-5000-COMPACT-QUADROHMS-5000-122022-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850052737016Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737023Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737030Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737047Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737054Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737061Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
G625R8003403Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2026-08-27
00860006478988HMS-5000-6-MINI-QUADROHyperbaric Modular Systems Inc.CBF2026-05-05
08906124945116TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124944713TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-02-12
G625R8003410Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-08-20
00850011262016PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2025-07-14
00860006478919HMS-5000Hyperbaric Modular Systems Inc.CBF2025-06-16
G625R800340Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-06-02
08906124943051TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
G623430US Hyperbaric NetworkUS Hyperbaric Network LLCCBF2025-05-02
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCCBF2024-11-21
08906124941477TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-09-03
00852834007003Newtowne Tent ChamberTYPHOON WATER WARES LTDCBF2024-05-28
B878430F0RevitalairOXAVITA S.R.L.CBF2024-01-19
08906124940012TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2023-09-29
00850011262009PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2023-08-07
00860006478964HMS-1000Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478926HMS-4000Hyperbaric Modular Systems Inc.CBF2023-08-01
00860006478902HMS-5000-COMPACT-QUADROHyperbaric Modular Systems Inc.CBF2022-10-31
00852678007078Perry BaromedicalPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852678007122BaramedPERRY BAROMEDICAL CORPORATIONCBF2022-08-31