FDA.report

CoreTech

Primary DI
10810041980455
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP2031BLK
Device description
626 8" Lumbar Back Brace
Published
2023-02-08
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

Related Records

Product Codes

CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications

CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041980455PackageGS112In Commercial Distribution
00810041980458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198045510810041980455
00810041980458008100419804588100419804580810041980458

GMDN Terms

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.

Sterilization Methods

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 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

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04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
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00840252901904Therafit BeltsTherafin CorporationISR2023-07-06
00840252902062Therafit BeltsTherafin CorporationISR2023-07-06
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00840252902093Therafit BeltsTherafin CorporationISR2023-07-06
00840252902116Therafit BeltsTherafin CorporationISR2023-07-06
10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15
00645517585567TrulifeTRULIFE LIMITEDISR2022-12-31
06974567742786EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02
06974567742793EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02
06974567742809EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02
04719879641660ComfytopiaComfytopia, Inc.ISR2022-11-18