FDA.reportPublic FDA data

Vive

Primary DI
10810113570713
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2098BLK
Device description
Arm Compression Pump (Full System) Premium
Published
2023-06-23
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
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192358000Pressure Therapy System PT1003Xiamen Senyang Co., Ltd.2020-04-23IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113570713PackageGS12In Commercial Distribution
00810113570716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357071310810113570713
00810113570716008101135707168101135707160810113570716

GMDN Terms#

Term, Definition table
TermDefinition
Portable sequential venous compression systemA compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
false
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
00818323026702ViveLVA1077PK482024-01-12
00818323026719ViveLVA1077PK722024-01-12
00810226441385ViveLVA3177BLK2026-07-28
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
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06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
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08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
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