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
1745561036548559
1745561046235497
1745561048499157
1745561060286922
1745561061032704
1745561075672018
1745561079254687
1745561109684919
1745561125816434
1745561130683470
1745561166807673
1745561181664747
1745561188341779
1745561218047981
1745561218716476
1745561227586834
1745561234228027
1745561235452117
1745561235973431
1745561261132742
1745561270549764
1745561273537491
1745561276644314
1745561291740821
1745561296505523
1745561310834863
1745561316092926
1745561320325420
1745561375353371
1745561385583291
1745561398885899
1745561403354529
1745561427779455
1745561440681683
1745561442011896
1745561446013035
1745561447220145
1745561448938806
1745561452154066
1745561463591090
1745561476215152
1745561491811135

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

NDC

TRIPLE ANTIBIOTIC

Vive Health LLC

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

TRIPLE ANTIBIOTIC

Vive Health LLC

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

PMN

GUDID

200 records. Showing 1-40. Next