FDA.reportPublic FDA data

Freeze Sleeve

Primary DI
06974650930090
Brand
Freeze Sleeve
Company
Jiangsu Huanyi Industrial Co. LTD
Model
FS10027
Device description
Freeze Sleeve Turquoise L
Published
2023-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974650930090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974650930090069746509300906974650930090

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
415186065
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974650930014Freeze SleeveFS100012023-07-14
06974650930021Freeze SleeveFS11102/FS100022023-07-14
06974650930038Freeze SleeveFS11103/FS100032023-07-14
06974650930045Freeze SleeveFS11104/FS100042023-07-14
06974650930052Freeze SleeveFS100052023-07-14
06974650930069Freeze SleeveFS100062023-07-14
06974650930076Freeze SleeveFS100252023-07-14
06974650930083Freeze SleeveFS100262023-07-14
06974650930106Freeze SleeveFS100282023-07-14
06974650930113Freeze SleeveFS100292023-07-14
06974650930120Freeze SleeveFS100302023-07-14
06974650930137Freeze SleeveFS210012023-07-14
06974650930144Freeze SleeveFS210022023-07-14
06974650930151Freeze SleeveFS210032023-07-14
06974650930168Freeze SleeveFS210042023-07-14
06974650930175Freeze SleeveFS210052023-07-14
06974650930182Freeze SleeveFS210062023-07-14
06974650930199Freeze SleeveFS100312023-07-14
06974650930205Freeze SleeveFS111022023-07-14
06974650930212Freeze SleeveFS111032023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
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00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
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00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00810178880300Arctic FlexVIVE HEALTH LLCIME2025-04-04