FDA.reportPublic FDA data

TEKNA Manufacturing Pvt. Ltd.

Primary DI
08906124944713
Brand
TEKNA Manufacturing Pvt. Ltd.
Company
TEKNA MANUFACTURING PRIVATE LIMITED
Model
Modular Multiplace Hyperbaric Chamber
Catalog number
Modular Rectangular 6000 0 0 1 S/L
Device description
Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 1 patients in the main lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K002794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002794000MODEL 5000 MULTIPLACE HYPERBARIC THERAPYHypertec, Inc.2000-12-06CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906124944713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906124944713089061249447138906124944713

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.

Contacts#

Phone, Email table
PhoneEmail
+1(727)515-7379truhyperbarx@gmail.com

Regulatory Flags#

DUNS number
876896922
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906124945116TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 8 0 2 D/L2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 0 4 S/L2026-04-30
08906124943051TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 0 2 S/LModular Rectangular 6000 0 0 2 S/L2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 2 0 S/LModular Rectangular 6000 0 2 0 S/L2025-05-04
08906124941477TEKNA Manufacturing Pvt. Ltd.Hybrid 3200 series Monoplace Hyperbaric ChamberHybrid 3200/40 Monoplace Hyperbaric Chamber2024-09-03
08906124940012TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 + 0 0 8 2 D/LModular Rectangular 6000 + 0 0 8 2 D/L2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 + 0 0 8 2 D/L2023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00860006478940HMS-2000 Hyperbaric Modular Systems Inc.CBF2023-08-02
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
00852682007996Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2022-08-29
00852682007941Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007958Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007934Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-05-01
00852834007065Newtowne HyperbaricsTYPHOON WATER WARES LTDCBF2020-03-13
00852682007903Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01
00852682007927Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01