FDA.reportPublic FDA data

RegeniCool™ Pro

Primary DI
00850063323567
Brand
RegeniCool™ Pro
Company
Unite Medical, LLC
Model
RC-PRO-1000
Catalog number
RC-PRO-1000
Device description
RegeniCool™ Pro is a cold compression therapy system intended to provide localized cold therapy through circulating chilled water for the temporary reduction of pain and swelling following surgery or injury. The system consists of a portable base unit with an integrated reservoir and pump that circulates chilled water through a compatible therapy wrap applied to the treatment area. The device offers adjustable therapy settings that control water circulation timing and hydraulic pressure within the wrap. It is intended for use in clinical or home settings under the direction of a licensed healthcare provider. The device does not utilize pneumatic (air-driven) compression. Compatible wraps are packaged separately.
Published
2026-03-13
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

Contact Domains#

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
00850063323567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063323567008500633235678500633235670850063323567

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy systemAn assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-868-6483support@unitemedical.net

Regulatory Flags#

DUNS number
117553945
Device count
1
DM exempt
false
Premarket exempt
true
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
00850063323550RegeniCool™ ProRC-PRO-1000RC-PRO-10002026-03-13
00850012035312Unite Medical®Cryo Pneumatic Shoulder - UniversalCyro36702024-06-20
00850052096915Unite Medical®Tall Walking Boot - Pneumatic (XSmall)PWB6061-XS-T2024-06-20
00850052096922Unite Medical®Tall Walking Boot - Pneumatic (Small)PWB6061-S-T2024-06-20
00850052096939Unite Medical®Tall Walking Boot - Pneumatic (Medium)PWB6061-M-T2024-06-20
00850052096946Unite Medical®Tall Walking Boot - Pneumatic (Large)PWB6061-L-T2024-06-20
00850052096953Unite Medical®Tall Walking Boot - Pneumatic (XLarge)PWB6061-XL-T2024-06-20
00850063323000Unite Medical®Short Walking Boot - Pneumatic (XLarge)PWB6061-XL-S2024-06-20
00850063323017Unite Medical®Short Walking Boot - Pneumatic (Large)PWB6061-L-S2024-06-20
00850063323024Unite Medical®Short Walking Boot - Pneumatic (Medium)PWB6061-M-S2024-06-20
00850063323031Unite Medical®Short Walking Boot - Pneumatic (Small)PWB6061-S-S2024-06-20
00850063323048Unite Medical®Short Walking Boot - Pneumatic (XSmall)PWB6061-XS-S2024-06-20
00850012035121Unite Medical®Universal ROM Knee BraceKO32332023-12-28
00850012035138Unite Medical®Deluxe Universal ROM Knee BraceKO3233-12023-12-28
00850012035244Unite Medical®Single Upright Knee Orthosis (Left, Universal)KO4351L2023-12-28
00850012035251Unite Medical®Single Upright Knee Orthosis (Right, Universal)KO4351R2023-12-28
00850012035329Unite Medical®Suspension Sleeve (Universal)SS23972023-12-28
00850012035367Unite Medical®Double Upright Knee Orthosis (Left,Small)KO4552L-S2023-12-28
00850012035374Unite Medical®Double Upright Knee Orthosis (Right, Small)KO4552R-S2023-12-28
00850012035381Unite Medical®Double Upright Knee Orthosis (Left, Medium)KO4552L-M2023-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063323550RegeniCool™ ProUnite Medical, LLCILO2026-03-13
06973641886880CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886897CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886903CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886910CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886927CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886934CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886941CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886958CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887061CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887078CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887085CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887092CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887108CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887115CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887122CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887139CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
00850033615616ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UFTHERMOTEK, INC.ILO2026-02-23
00850033615647THERAPY SYSTEM, ARTEK PRO-02THERMOTEK, INC.ILO2026-02-23
00850033615081ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZETHERMOTEK, INC.ILO2026-02-21
00850033615104ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13"THERMOTEK, INC.ILO2026-02-21
00850033615135ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13"THERMOTEK, INC.ILO2026-02-21
00850033615142ThermoTek WRAP, KNEE, ROM BRACE, L, 13"THERMOTEK, INC.ILO2026-02-21
00850033615159ThermoTek WRAP, FOOT/ANKLE, SPU , UFTHERMOTEK, INC.ILO2026-02-21
00850033615166ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UFTHERMOTEK, INC.ILO2026-02-21
00850033615173ThermoTek WRAP, HIP, STND, SPU, UNFILLEDTHERMOTEK, INC.ILO2026-02-21
00850033615180ThermoTek WRAP, KNEE, ROM BRACE, M, 13"THERMOTEK, INC.ILO2026-02-21
00850033615197ThermoTek WRAP, KNEE, ROM BRACE, XL, 13"THERMOTEK, INC.ILO2026-02-21
00850033615203ThermoTek WRAP, ARM, SPU, UNFILLEDTHERMOTEK, INC.ILO2026-02-21