FDA.report

VIVE Health LLC

Matched from indexed company URL: VIVE HEALTH LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30111912553011191255VIVE Health LLC1Y2026-01-018955 Fontana Del Sol Way Naples FL US 34109

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1745561290459002K252517Manual Wheelchair (SYIV100A008)IOR2025-10-03
1745561183273259K251638Mobility Scooter (MS160C)INI2025-07-22
1745561351030074K251159Power wheelchairITI2025-12-22
1745561781630639K251130Portable Oxygen Concentrator (JM-P50A)CAW2025-08-21
1745561920457587K250817Coretech Compression System (Coretech RHB3003)JOW2025-08-08
1745561257748097K250368Wearable Breast Pump (Model S21)HGX2025-05-30
1745561720255153K242982Mobility Scooter (MS160A)INI2025-01-31
1745561928072296K242791Electric wheelchair (KR-8807)ITI2024-11-12
1745561581859897K242736Portable Oxygen Concentrator (Spirit-3)CAW2025-06-05
1745561568032821K242471Power Wheelchair (W5538)ITI2024-11-18
1745561218676277K240981Air compression leg massagerIRP2024-08-02
1745561554672311K240913Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)ITI2024-05-31
1745561939948465K240255Electric Wheelchair (JLE-W01A-2023)ITI2024-08-07
1745561745751468K240012Mobility Scooter (W3431)INI2024-05-02
1745561962902803K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)NUH2024-02-12
1745561599466557K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)NUH2024-07-19
1745561641657595K232783Power wheelchair (Model: JMPW-01W)ITI2024-01-19
1745562049085187K232713Blood Pressure MonitorDXN2023-11-28
1745561834636510K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)IOR2023-09-15
1745561550712366K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)IOR2023-09-15
1745561967643439K231564Skin and Wound CleanserFRO2023-11-10
1745561640481556K231110Manual Wheelchair (A006)IOR2023-06-16
1745561066988988K222408Disposable Safety LancetFMK2022-11-29
1745561061556397K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDXN2022-12-01
1745561579447591K222034RightLance Blood Lancing SystemQRL2022-09-07
1745561386036181K220886Upper Arm Type Blood Pressure MonitorDXN2022-07-27
1745562055440016K213598LUOFUCON Collagen Wound DressingKGN2022-09-20
1745561627515993K211123LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelFRO2022-04-22
1745561788809259K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZD2021-07-02
1745561577705776K202891Blood Pressure MonitorDXN2021-03-09
1745561932047522K201982Air compression therapy system FO-3001; Air compression therapy system FO-3008IRP2021-03-25
1745561612764887K201354TENS & PMSNGX2020-12-11
1745561672553783K200346Wrist Type Blood Pressure MonitorDXN2020-12-17
1745561475959578K200177Low-frequency Multi-function physiotherapy instrumentNUH2021-03-25
1745561242539657K200019Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)LZA2020-04-06
1745561393720179K192087Combo Electrotherapy DeviceNUH2019-11-01
1745561824136704K191802Electric Breast PumpHGX2020-01-16
1745561215292609K191657Bioland Blood Glucose Monitoring SystemNBW2020-03-20
1745561766371547K191593Digital Automatic Blood Pressure Monitor MD36 SeriesDXN2019-07-22
1745561789986647K183288Transcutaneous Electrical Nerve StimulatorNUH2019-07-30
1745561717792204K182495Electronic Blood Pressure MonitorDXN2019-03-03
1745561588422681K182411Scooter, Model: R-100INI2019-06-24
1745561603368709K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorIPF2018-09-07
1745561643845966K181478Roosin Xeroform Petrolatum DressingFRO2019-09-13
1745561448425152K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL2018-10-29
1745561305624256K172141Pulse OximeterDQA2018-04-04
1745561389776173K171889Reusable Blood Pressure CuffDXQ2017-12-19
1745561287776884K171578Infrared thermometerFLL2017-11-30
1745561340820798K170965Fingertip Pulse OximeterDQA2017-11-03
1745562056898206K170466Automatic Blood Pressure Monitor Model LD-518 & LD-537DXN2017-10-27
1745561929486165K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203NUH2017-05-11
1745561256733709K161938Fingertip Pulse OximeterDQA2017-05-08
1745562046943669K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)CAF2017-09-06
1745561564761238K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2WGXY2016-10-30
1745561300580107K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36FLL2016-05-27
1745561430248653K143124KA01 Chitosan Wound DressingKGN2015-01-26
1745561165965817K140582FINGERTIP PULSE OXIMETERDQA2014-08-28
1745562014594969K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
1745561633706827K130982LERADO, POWER WHEELCHAIRITI2014-02-28
1745562031721976K123030COMPRESSOR NEBULIZER MODEL MCN-S600XXCAF2013-12-19
1745561355553512K122976BODY FAT SCALE MODEL SF-371MNW2013-01-04
1745561695841597K121719SM TENS & PMSNGX2013-05-10
1745561865390745K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMFRO2013-02-14
1745561473298538K120058TRANSTEK BLOOD PRESSURE MONITORDXN2012-01-31
1745561402280013K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRIOR2012-04-18
1745561946283408K102624AVITA WRIST TYPE BLOOD PRESSURE MONITORDXN2010-12-16
1745561012398916K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100DXQ2009-10-28
1745561057277040K091578LIFT CHAIR, MODEL T3INO2009-12-02
1745561286378532K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
1745561166702735K082542ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-ADXQ2008-09-17
1745561320557617K070501RUIKE 3421 POWERED WHEELCHAIRITI2007-03-22
1745562065977734K062676RUIKE, MODEL 3331INI2006-12-14
1745561870906062K062646RUIKE, MODEL 3411INI2007-02-05
1745561619009189K062645RUIKE, MODEL 3431INI2006-12-19
1745561108002475K062033BP 101 DIGITAL BLOOD PRESSURE MONITORDXN2007-03-23
1745561755436461K053574MEDLINE PEDIATRIC WHEELCHAIRSIOR2006-01-25
1745561221746116K051699SEJOY, MODEL MT-403FLL2006-02-06
1745561581036987K043238COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESCAF2005-07-06
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Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DXN122023-11-28
ITI82025-12-22
INI72025-07-22
IOR62025-10-03
NUH62024-07-19
DQA52018-04-04
FRO42023-11-10
FLL42018-10-29
DXQ32017-12-19
CAF32017-09-06
CAW22025-08-21
HGX22025-05-30
IRP22024-08-02
KGN22022-09-20
NGX22020-12-11
JOW12025-08-08
FMK12022-11-29
QRL12022-09-07
BZD12021-07-02
LZA12020-04-06
NBW12020-03-20
IPF12018-09-07
GXY12016-10-30
MNW12013-01-04
INO12009-12-02

PMA

PMN

Applications

GUDID

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-03-06

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC

Vive

2026-02-17

VIVE HEALTH LLC