FDA.reportPublic FDA data

ALLEVA MEDICAL (D.G.) LTD

Matched from indexed company URL: Alleva Medical, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103081463010308146ALLEVA MEDICAL (D.G.) LTD1N2026-01-0176 San Lian Nan Road, Lu Wu Administration District, Changping Town Dongguan City Guangdong CN 523587
30217675513021767551ALLEVA MEDICAL DEVICES1N2026-01-011050 W. Central Avenue, Unit B Brea CA US 92821
30159896883015989688ALLEVA MEDICAL USA LLC1Y2020-04-25Suite 205, 2460 General Armistead Avenue Norristown PA US 19403

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3031731329984392K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemOMP2023-02-09
1664061365773737K213906extriCARE 1000 Negative Pressure Wound Therapy SystemOMP2023-03-08
3031732071387157K213906extriCARE 1000 Negative Pressure Wound Therapy SystemOMP2023-03-08
1664061852895642K191107PlexusJOW2019-08-27
1664061192407809K172779AIROS 8 Sequential Compression DeviceJOW2018-06-22
1664061060923887K172770AIROS 6 Sequential Compression DeviceJOW2018-06-22
1664062038818577K150333MedSource Sharps DartMMK2015-05-08
1664061584927801K143362extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canisterOMP2015-02-03
3031731803714912K143362extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canisterOMP2015-02-03
1664061162602135K142168NATURE'S BOND 600 AND NATURE'S BOND 603HGX2014-12-04
3031731170111043K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing KitOMP2014-09-19
1664061850876067K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing KitOMP2014-09-19
1664061531454387K132252EXTRICARE 100CC/ 250CC/ 400CC CANISTERSOMP2013-09-27
3031731823762132K132252EXTRICARE 100CC/ 250CC/ 400CC CANISTERSOMP2013-09-27
1664061971670811K132225EXTRICAREOMP2014-05-15
1664061545652099K131464EXTRICARE NPWT FOOT DRESSINGOMP2013-08-13
1664061283902012K110078EXTRICAREOMP2012-02-10
3031731726914487K110078EXTRICAREOMP2012-02-10
1664061473087559K081932ENDEARE BREAST PUMPHGX2009-01-22
1664061409697895K031611P4-FITNESSNGX2004-09-29
2351291135009082
1664061188683845
1664061296930170
1664061321853395
2351291444169429
1664061883315102
1664061913971982
1664061978125367
3031731124726295
3031731185550840
3031731238085205
3031731380794283
3031731391451942
3031731452429458
1664061473087559
3031731481894182
1664061486398137
3031731515772074
1664061539543682
3031731545711634
1664061560909655
1664061700731248
1664061801532494
3031731832133498
1664061834031910
1664061887421199
1664061934753353
1664061973835484
1664061974472179
1664062043111069

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMP182023-03-08
JOW42019-08-27
HGX22014-12-04
MMK12015-05-08
NGX12004-09-29

PMN#

Plexus

2019-08-27

Alleva Medical (D.G.) Ltd

GUDID#

Plexus - The Plexus RP100 Portable DVT Prevention Therapy Device is a single-patient, portable, rechargeable, battery-powered, electronic device designed to stimulate blood flow and increase venous flow velocity by providing a defined pattern of intermittent pressure. The device consists of a hard-plastic outer casing (containing the electronics and pump unit) attached to a soft pressure garment sleeve with an internal air bladder. The Plexus RP100 has one therapy mode that provides a preset pattern of intermittent pressure to the lower leg. To use the device, the patient wraps the pressure garment around his/her calf tightly. When the device is turned on, air flows from the air pump into the air bladder inside the pressure sleeve, providing intermittent pneumatic pressure.

ALLEVA MEDICAL LIMITED

2026-01-14

Plexus - The Plexus RP100 Portable DVT Prevention Therapy Device is a single-patient, portable, rechargeable, battery-powered, electronic device designed to stimulate blood flow and increase venous flow velocity by providing a defined pattern of intermittent pressure. The device consists of a hard-plastic outer casing (containing the electronics and pump unit) attached to a soft pressure garment sleeve with an internal air bladder. The Plexus RP100 has one therapy mode that provides a preset pattern of intermittent pressure to the lower leg. To use the device, the patient wraps the pressure garment around his/her calf tightly. When the device is turned on, air flows from the air pump into the air bladder inside the pressure sleeve, providing intermittent pneumatic pressure.

ALLEVA MEDICAL LIMITED

2026-01-14

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