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
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14
00810226440630ViveSUP3168BGEM2026-07-14
00810226440647ViveSUP3168BGEL2026-07-14
00810226440654ViveSUP3168BGEXL2026-07-14
00810226440661ViveSUP3168BGE2XL2026-07-14
00810226440678ViveSUP3168BLKS2026-07-14
00810226440685ViveSUP3168BLKM2026-07-14
00810226440692ViveSUP3168BLKL2026-07-14
00810226440708ViveSUP3168BLKXL2026-07-14
00810226440715ViveSUP3168BLK2XL2026-07-14
00810226440739ViveSUP3173BLKS2026-07-14
00810226440746ViveSUP3173BLKM2026-07-14
00810226440753ViveSUP3173BLKL2026-07-14
00810226440760ViveSUP3173BLKXL2026-07-14
00810226440777ViveSUP3173BLK2XL2026-07-14
00810226440784ViveSUP3173BGES2026-07-14
00810226440791ViveSUP3173BGEM2026-07-14
00810226440807ViveSUP3173BGEL2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776100013Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100020Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100037Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100044Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100051Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100099Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102499Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102505Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102512Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102529Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102536Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103007Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103014Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103021Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103038Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103045Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105957Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105964Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105971Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105988Neotech CareNEOTECH CARE INC.IQE2026-07-14
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