FDA.reportPublic FDA data

VIVE

Primary DI
00818323020441
Brand
VIVE
Company
VIVE HEALTH LLC
Model
MOB1014BLK
Device description
Forearm Crutches (Black)
Published
2024-05-01
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
IPRCrutch

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323020448PackageGS18In Commercial Distribution
00818323020441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302044810818323020448
00818323020441008183230204418183230204410818323020441

GMDN Terms#

Term, Definition table
TermDefinition
Forearm support crutch"A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one or more legs and a padded support or ""trough"" in a horizontal position for the user to rest the forearm. The hand wraps around a grip at the end of the forearm support. The device may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is particularly suited to individuals who cannot rest their weight on their hands."

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
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12
00810226442917Vive BreatheLVA3196CLR10PAK2026-10-12
00810226442924ViveLVA1025PBU2026-10-12
00810226442931ViveLVA1025GBU2026-10-12
00810226442948ViveLVA1026PBU2026-10-12
00810226442955ViveLVA1026GBU2026-10-12
00810226442962ViveLVA3185BLKL2026-10-12
00810226440586ViveSUP3172BLKS2026-10-09
00810226442610ViveRHB3084RM2026-10-09
00810226442627ViveRHB3084RL2026-10-09
00810226442634ViveRHB3084LL2026-10-09
00810226442641ViveRHB3084LM2026-10-09
00810226442757ViveSUP3172BLKM2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980068410994GARVEEGuangdong Dayang Medical Technology Co.,LtdIPR2026-10-07
06979977310020TMCCEShen Zhen Shi Fan Fen Shu Technology Co., Ltd.IPR2026-08-21
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"Dynarex CorporationIPR2026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"Dynarex CorporationIPR2026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"Dynarex CorporationIPR2026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"Dynarex CorporationIPR2026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"Dynarex CorporationIPR2026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"Dynarex CorporationIPR2026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"Dynarex CorporationIPR2026-07-31
06979977310013ThreemartShen Zhen Shi Fan Fen Shu Technology Co., Ltd.IPR2026-06-10
00199536930124BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930131BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930148BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930155BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930162BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930179BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
06975185620159BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDIPR2026-01-07
06972223254703CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254710CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254727CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254734CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254697CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-11
06972855535065Adjustable Aluminum CrutchesJiangsu Jumao X-Care Medical Equipment Co.,LtdIPR2025-07-08
06950715505571cofoeCofoe Medical Technology Co.,LtdIPR2024-12-09
00850632007980True Comfort Quad CaneHOME AIDE DIAGNOSTICS, INC.IPR2024-10-08
10850632007987True Comfort Quad CaneHOME AIDE DIAGNOSTICS, INC.IPR2024-10-08
10818323020448VIVEVIVE HEALTH LLCIPR2024-05-01
00860009370609Medzah Aluminum Crutches SmallMedzah IndustriesIPR2024-01-23
00860009370616Medzah Aluminum Crutches MediumMedzah IndustriesIPR2024-01-23
00860009370623Medzah Aluminum Crutches TallMedzah IndustriesIPR2024-01-23