FDA.reportPublic FDA data

Vive

Primary DI
10810041989496
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3006BLKXL
Device description
Elastic Posture Corrector (XL)
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQEOrthosis, Lumbar
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041989496PackageGS120In Commercial Distribution
00810041989499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198949610810041989496
00810041989499008100419894998100419894990810041989499

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113579665ViveVIVE HEALTH LLCITQ2026-02-09
00810113579672ViveVIVE HEALTH LLCITQ2026-02-09
00810113579689ViveVIVE HEALTH LLCITQ2026-02-09
00810113579696ViveVIVE HEALTH LLCITQ2026-02-09
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810179882440CopperFitIdeavillage Products CorpITQ2026-01-13
16974500613576Knee BraceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613583Knee braceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
00810113683065ManaEZ ROM Ice ShortManamed, Inc.ITQ2025-10-17
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.ITQ2025-10-03
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00636257207727MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207734MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207741MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207758MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207765MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207772MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207789MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
06971503604528comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.ITQ2025-08-28
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
00190446660453PROCAREDJO, LLCITQ2025-07-23
00749756395489DeRoyalDEROYAL INDUSTRIES, INC.ITQ2025-07-23
00819567017891ComfytopiaComfytopia, Inc.ITQ2025-07-09
00819567017907ComfytopiaComfytopia, Inc.ITQ2025-07-09
00854194003138ComfytopiaComfytopia, Inc.ITQ2025-07-09
10810113579891ViveVIVE HEALTH LLCITQ2025-07-08
10810113579907ViveVIVE HEALTH LLCITQ2025-07-08