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Data / Medical devices / United States / Proactive Medical Products

Proactive Medical Products: FDA-registered device maker in Mount Vernon, NY, United States, 10 510(k) clearances

Proactive Medical Products is registered with the FDA (registration 3009327812) in Mount Vernon, NY, United States. It lists 34 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009327812
Address
590 Franklin Ave, Mount Vernon, NY, United States, 10550
Owner or operator
PROACTIVE MEDICAL PRODUCTS LLC (10039097)
Roles
Complaint file establishment, Repackager or relabeler
First device listed
May 1, 2015
Registered through
2026
Brand names listed
Basic Alarm, Advanced Alarm, Classic Sensor Pads, Pro Temp Infrared Non-Contact Thermometer, Protekt Aire, Protekt BP, Protekt Concentrator, Protekt Cushion Cover, Protekt Define, Protekt Finger Pulse Ox and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Complaint file establishmentaccessdata.fda.gov
Adaptor, HygieneILS1Complaint file establishmentaccessdata.fda.gov
Armrest, WheelchairIML1Complaint file establishmentaccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Complaint file establishmentaccessdata.fda.gov
Bed, ManualFNJ1Complaint file establishmentaccessdata.fda.gov
Bed, Therapeutic, Ac-Powered, Adjustable Home-UseLLI2Complaint file establishmentaccessdata.fda.gov
CaneIPS1Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Complaint file establishmentaccessdata.fda.gov
CrutchIPR1Complaint file establishmentaccessdata.fda.gov
Cushion, FlotationKIC1Complaint file establishmentaccessdata.fda.gov
Cushion, WheelchairIMP1Repackager or relabeleraccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Complaint file establishmentaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Complaint file establishmentaccessdata.fda.gov
Footrest, WheelchairIMM1Complaint file establishmentaccessdata.fda.gov
Generator, Oxygen, PortableCAW2Complaint file establishmentaccessdata.fda.gov
Lift, Patient, Ac-PoweredFNG2Complaint file establishmentaccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Complaint file establishmentaccessdata.fda.gov
Mask, ScavengingKHA1Complaint file establishmentaccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Complaint file establishmentaccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Repackager or relabeleraccessdata.fda.gov
Monitor, Bed PatientKMI1Complaint file establishmentaccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Complaint file establishmentaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Complaint file establishmentaccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Complaint file establishmentaccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Complaint file establishmentaccessdata.fda.gov
Protector, Skin PressureFMP1Complaint file establishmentaccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Complaint file establishmentaccessdata.fda.gov
Stand, InfusionFOX1Complaint file establishmentaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
Table, MechanicalINW1Complaint file establishmentaccessdata.fda.gov
Walker, MechanicalITJ1Complaint file establishmentaccessdata.fda.gov
Wheelchair, MechanicalIOR1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 16, 2025K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)CAWSubstantially EquivalentShenzhen Harveymed Technology Co., Ltd.accessdata.fda.gov
April 5, 2019K181919Patient MonitorMWISubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
June 21, 2018K170886HOMED Mesh NebulizerCAFSubstantially EquivalentShenzhen Homed Medical Device Co., Ltd.accessdata.fda.gov
September 19, 2017K163135Finger Pulse OximeterDQASubstantially EquivalentShenzhen Fitfaith Technology Co.,Ltdaccessdata.fda.gov
February 25, 2016K153135VITAL SIGNS MONITORMWISubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
April 2, 2015K150545Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)DXNSubstantially EquivalentSejoy Electronics & Instruments Co., Ltd.accessdata.fda.gov
December 4, 2014K141105PULSE OXIMETERDQASubstantially EquivalentHunan Accurate Bio-Medical Technology Co., Ltd.accessdata.fda.gov
October 8, 2009K090361REMOTE INFRARED THERMOMETER, MODEL RC002FLLSubstantially EquivalentRycom Electron Technology Limitedaccessdata.fda.gov
July 24, 2009K090007JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000CAWSubstantially EquivalentDanyang Jumao Healthcare Equipment Co., Ltd.accessdata.fda.gov
October 7, 2008K082784JUMAO MANUAL WHEELCHAIRIORSubstantially EquivalentDanyang Jumao Healthcare Equipment Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.