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Data / Medical devices / United States / Valmar Surgical Supplies, Inc.

Valmar Surgical Supplies, Inc.: FDA-registered device maker in Lakewood, NJ, United States, 7 510(k) clearances

Valmar Surgical Supplies, Inc. is registered with the FDA (registration 3008771621) in Lakewood, NJ, United States. It lists 22 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 31, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number
3008771621
Address
1750 Cedarbridge Suite 4, Lakewood, NJ, United States, 08701
Owner or operator
Valmar Surgical Supplies, Inc. (10034554)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
January 9, 2013
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Belt, WheelchairIQB1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Brake, Extension, WheelchairIMW1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Components, WheelchairKNN1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Cushion, WheelchairIMP1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Lift, Patient, Ac-PoweredFNG2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Respirator, SurgicalMSH2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Restraint, Wheelchair, Non-ProtectiveKID1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Walker, MechanicalITJ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Wheelchair, MechanicalIOR1Complaint file establishment, Repackager or relabeleraccessdata.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
March 31, 2026K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 15, 2023K232199Bariatric 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)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 15, 2023K232198Reclining 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)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
June 5, 2023K231320Zhenjiang Assure Mechanical Wheelchair,model:K1IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
May 25, 2018K172889Infrared ThermometerFLLSubstantially EquivalentShenzhen Pacom Medical Instruments Co., Ltd.accessdata.fda.gov
May 8, 2012K112266POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLORLYZSubstantially EquivalentShandong Zhiyuan Medical Products Co., Ltd.accessdata.fda.gov
April 18, 2012K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRIORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 31, 2026. 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.