FDA.reportPublic FDA data

CoreTech

Primary DI
00810178888092
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3134BLK
Device description
627 Ultra LSO
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IPTOrthosis, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810178888092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178888092008101788880928101788880920810178888092

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178888665CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888894CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889075CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889174CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889259CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889266CoreTechVIVE HEALTH LLCIPT2026-05-05
00850071315264TrendOrthofix US LLCIPT2026-04-25
00850071315240TrendOrthofix US LLCIPT2026-04-14
00850071315257TrendOrthofix US LLCIPT2026-04-14
00850071315271TrendOrthofix US LLCIPT2026-04-14
00810113682716Tailback2-56Manamed, Inc.IPT2025-09-19
00810113682723Tailback2-64Manamed, Inc.IPT2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IPT2025-08-05
04823097722114"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722121"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722138"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722145"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722152"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722169"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722176"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17
04823097722183"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722190"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722206"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722213"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722220"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722237"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722244"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17
04823097722329"TM ""Rehabilitimed"" OT-1V-U Lp Comfort"REABILITIMED TOVIPT2025-05-17