FDA.reportPublic FDA data

Dr. Aktive

Primary DI
06973641880772
Brand
Dr. Aktive
Company
Chengdu Cryo-push Medical Technology Co.,Ltd.
Model
A02-C-032-B2
Device description
Hot and Cold Compression System-Right shoulder cuff
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973641880772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973641880772069736418807726973641880772

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal/compression therapy system wrapA non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.

Regulatory Flags#

DUNS number
543049236
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973641880444Dr. AktiveA02-C-032-A2026-07-21
06973641880512Dr. AktiveA02-C-032-B12026-07-21
06973641880680Dr. AktiveA02-C-032-E12026-07-21
06973641880765Dr. AktiveA02-C-032-E22026-07-21
06973641880789Dr. AktiveA02-C-032-C2026-07-21
06973641880796Dr. AktiveA02-C-032-G2026-07-21
06973641880802Dr. AktiveA02-C-032-T2026-07-21
06973641880819Dr. AktiveA02-C-032-F2026-07-21
06973641880826Dr. AktiveA02-C-0322026-07-21
06973641880871CryoRxKRP/MYY-I6-M2026-07-19
06973641887146CRYOPUSHKRP/MYY-M2026-03-12
06973641888518CryoRxD-KRP/MYY-MKRP/MYY-M2025-09-16
06973641886880CRYOPUSHKRP/MYY-B6-M2026-03-12
06973641886897CRYOPUSHKRP/MYY-E6-M2026-03-12
06973641886903CRYOPUSHKRP/MYY-C6-M2026-03-12
06973641886910CRYOPUSHKRP/MYY-H6-M2026-03-12
06973641886927CRYOPUSHKRP/MYY-A6-M2026-03-12
06973641886934CRYOPUSHKRP/MYY-T6-M2026-03-12
06973641886941CRYOPUSHKRP/MYY-F6-M2026-03-12
06973641886958CRYOPUSHKRP/MYY-G6-M2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880871CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-19
00840397513352Sharper ImageMerchsource, LLCIRP2026-06-28
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
00860015634924POWERPRESS UNITNEO MEDICIRP2026-03-31
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
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