FDA.reportPublic FDA data

Youwen

Primary DI
06975803350031
Brand
Youwen
Company
Shanghai Youwen Medical Technology Co.,Ltd.
Model
blue head
Device description
Youwen cold therapy head pad
Published
2025-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975803350031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975803350031069758033500316975803350031

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544496113
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975803355012THERMA ZONE003-302022-12-09
06975803350000Youwenblue hand2025-09-25
06975803350017Youwen blue knee2025-09-25
06975803350024Youwenblue shoulder2025-09-25
06975803350048Youwenblue waist2025-09-25
06975803350055Youwenblue thigh2025-09-25
06975803350062Youwenblue hip2025-09-25
06975803350079Youwenblue blanket2025-09-25
06975803350086Youwenblue elbow2025-09-25
06975803350093Youwenblue ankle2025-09-25
06975803350109Youwenblue universal2025-09-25
06975803350116Youwenblue universal 2.02025-09-25
06975803350123Youwenblue face 2025-09-25
06975803350130Youwenblue face 2.02025-09-25
06975803350147Youwenblue face 3.02025-09-25
06975803350154Youwenblue shoulder 3.02025-09-25
06975803350161Youwenblue knee 3.02025-09-25
06975803350178Youwenblue blanket 2.02025-09-25
06975803350185Youwen black hand2025-09-25
06975803350192Youwenblack knee2025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.ILO2023-04-05
08809802643260CTC-7DAESUNG MAREF CO.,LTD.ILO2022-05-09
00810041988126ViveVIVE HEALTH LLCILO2021-11-30