FDA.reportPublic FDA data

Eva Scalp Cooling System

Primary DI
89080300020370
Brand
Eva Scalp Cooling System
Company
STEMTECH MEDICAL DEVICES PRIVATE LIMITED
Model
EVACCK 1
Device description
EvaCool Coolant CanCoolant for Eva Scalp Cooling System - 5000ml Coolant Can
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
PMCScalp Cooling System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMCScalp Cooling SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252289000Eva Scalp Cooling SystemStemtech Medical Devices Private Limited2025-11-25PMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
89080300020370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8908030002037089080300020370

GMDN Terms#

Term, Definition table
TermDefinition
Scalp cooling system, hair lossAn assembly of electrically-powered devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.

Regulatory Flags#

DUNS number
854383009
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
89080300020134Eva Scalp Cooling System EVACCK 12026-05-04
89080300020202Eva Scalp Cooling SystemEVACCK 12026-05-04
89080300020066Eva Scalp Cooling SystemESCS 42026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
89080300020134Eva Scalp Cooling System STEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020202Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020066Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-01
00850051245239AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245246AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245253AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245192AMMACooler Heads Care, Inc.PMC2025-12-22
00850051245116AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245123AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245130AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245000AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245017AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245024AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245031AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245048AMMACooler Heads Care, Inc.PMC2023-10-24
00851682007562Cooler HeadsPATHWAY, LLCPMC2022-11-07
B561PSCSKITL251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITLA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITM251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITSA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561CAPBATCH1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561CAPSIZINGPACKA1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561COOLANTBATCH1PSCS CoolantPAXMAN COOLERS LIMITEDPMC2022-03-07
B561PSCSCAPMEDSML0Paxman Cooling CapPAXMAN COOLERS LIMITEDPMC2022-03-07
00850036106005DigniCap® DeltaDignitana ABPMC2022-02-02
00850036106036DigniCap® DeltaDignitana ABPMC2022-02-02
00850036106074DigniCap® DeltaDignitana ABPMC2022-02-02