FDA.reportPublic FDA data

Z-ONE

Primary DI
03858894530434
Brand
Z-ONE
Company
ZAMAR MEDICAL d.o.o.
Model
MG455BC00E
Published
2025-06-12
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
ILOPack, Hot Or Cold, Water Circulating
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242754000ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O.2025-05-05IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03858894530434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03858894530434038588945304343858894530434

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal/compression therapy system control unitAn electrically-powered device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury and/or orthopaedic surgery (e.g., pain, swelling, inflammation). It includes a fluid pump, air pump, controls, and either a heater or a means for cold therapy (e.g., refrigeration unit, addition of independently cooled ice water) or both. The unit may be programmable for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500686107
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809315676984LF900DAESUNG MAREF CO.,LTD.IRP2023-03-08
08809277423466WONJINWONJIN MULSAN CO.LTDIRP2022-01-11
088098026404054 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-22
08809315672252SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672269SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672276SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672283SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672290SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672306SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672375SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672382SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672399SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672405SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672412SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809802640221LF400DAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403754 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403824 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403994 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026404124 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17