FDA.reportPublic FDA data

Vive

Primary DI
00810041980151
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2022
Device description
Compression Back Ice Wrap
Published
2024-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041980158PackageGS16In Commercial Distribution
00810041980151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198015810810041980158
00810041980151008100419801518100419801510810041980151

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA non-powered 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, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IQE2025-08-05
00636257203651MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203668MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203675MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203682MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203699MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203705MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203712MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203729MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203736MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203743MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203750MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203767MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204801MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204818MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204825MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204832MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204849MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204856MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204863MEDIMEDI MANUFACTURING, INC.IQE2025-06-24