FDA.reportPublic FDA data

Vive

Primary DI
00810113573403
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB3001BLK
Device description
Ergonomic Shoulder Pulley
Published
2023-08-23
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
IODComponents, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113573400PackageGS140In Commercial Distribution
00810113573403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357340010810113573400
00810113573403008101135734038101135734030810113573403

GMDN Terms#

Term, Definition table
TermDefinition
Body/limb elastic exerciserAn exercise apparatus intended to primarily strengthen one or several major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance. It typically consists of elastic bands, cords, straps, tubes, or cables often with handles/grips and sometimes anchors for attachment to fixtures (e.g., doors). The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges, flies, and raises; it may also be used to improve body flexibility and mobility or as an aid in physical rehabilitation after an injury (e.g., ankle sprain).

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
00810178887743ViveRHB3076M2026-08-07
00810041980229ViveSUP1064TAL2026-08-03
00810041980236ViveSUP1064BLU2026-08-03
00810041980243ViveSUP1064PNK2026-08-03
00810178885602ViveLVA2014PAK22026-08-03
00810226440722ViveMOB1163WHT2026-08-03
00810226441460ViveSUP1064GRY2026-08-03
00810226441477ViveSUP1064RED2026-08-03
00810226441484ViveSUP1064PUR2026-08-03
00810226441491ViveSUP1064PFL2026-08-03
00810226441507ViveSUP1064LPD2026-08-03
00810226441514ViveSUP1064USA2026-08-03
00810226441538ViveLVA3182BLK2026-08-03
00810226441545ViveLVA3180BGE2026-08-03
00810226441552ViveLVA3180BGEL2026-08-03
00818323021332ViveSUP1064BLK2026-08-03
00818323027358ViveLVA20142026-08-03
00818323026702ViveLVA1077PK482024-01-12
00818323026719ViveLVA1077PK722024-01-12
00810226441385ViveLVA3177BLK2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"Hausmann Enterprises, LLCIOD2025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"Hausmann Enterprises, LLCIOD2025-04-14
00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
00810113574356ViveVIVE HEALTH LLCIOD2024-07-17
00810113577296ViveVIVE HEALTH LLCIOD2024-07-17
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
00057475571184BIOS LivingThermor LtdIOD2023-09-18
10057475571181BIOS LivingThermor LtdIOD2023-09-18
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
00818323029529ViveVIVE HEALTH LLCIOD2023-08-02
00818323029536ViveVIVE HEALTH LLCIOD2023-08-02
10818323029526ViveVIVE HEALTH LLCIOD2023-08-02
10818323029533ViveVIVE HEALTH LLCIOD2023-08-02
G505MRBHS0Balance Harness M.A.S.S. Rehab, LLCIOD2023-08-01
G505MRHSH0Healing Solutions HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
10810041982350VIVEVIVE HEALTH LLCIOD2023-06-30
07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21
072900197338673DTutorMEDITOUCH LTDIOD2023-06-21
07290019733874LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733881LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733898ArmTutorMEDITOUCH LTDIOD2023-06-21