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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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.

Regulatory Flags#

DUNS number
500686107
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
03858894530069Thigh Thermic Wrap1ACS266A1ACS266A2026-10-12
03858894530083Knee/Calf Thermic Wrap1ACS267A1ACS267A2026-10-12
03858894530106Lumbar Thermic Wrap1ACS268A1ACS268A2026-10-12
03858894530120Shoulder Thermic Wrap1ACS269A1ACS269A2026-10-12
03858894530144Elbow/Wrist Thermic Wrap1ACS270A1ACS270A2026-10-12
03858894530168Anatomic Ankle Thermic Wrap1ACS272A1ACS272A2026-10-12
03858894530205Anatomic Knee Thermic Wrap1ACS279A1ACS279A2026-10-12
03858894530243Hip Thermic Wrap Right1ACS283A1ACS283A2026-10-12
03858894530267Hip Thermic Wrap Left1ACS284A1ACS284A2026-10-12
03858894530274Jaw Thermic Wrap1ACS2911ACS2912026-10-12
03858894530281Face Thermic Wrap1ACS2921ACS2922026-10-12
03858894530502ZT Cube - ZC3MG465AC30E2026-10-12
03858894530618ZT CLINICMG675AC20FMG675AC20F2026-10-12
03858894531257Full Leg Thermic Wrap Right1ACS200A1ACS200A2026-10-12
03858894531264Full Leg Thermic Wrap Left1ACS201A1ACS201A2026-10-12
03858894531271Anatomic Knee/Thigh Thermic Wrap1ACS205A1ACS205A2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.ILO2026-10-12
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.ILO2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31