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Data / Medical devices / United States / Lightning X Products, Inc

Lightning X Products, Inc: FDA-registered device maker in Charlotte, NC, United States, 7 510(k) clearances

Lightning X Products, Inc is registered with the FDA (registration 3012311599) in Charlotte, NC, United States. It lists 36 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 4, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Lightning X Products, Inc
FDA registration number
3012311599
Address
2365 Tipton Drive, Charlotte, NC, United States, 28206
Owner or operator
Lightning X Products, Inc (10051897)
Roles
Manufacturer, Repackager or relabeler
First device listed
October 9, 2020
Registered through
2027
Brand names listed
BattleSeal 3" x 48" Hemostatic Gauze, BattleSeal 4"x4" Hemostatic Gauze, Everready Nasal Cannula, Everready Nonrebreather Mask, Lightning X 1" Cloth Medical Tape, Lightning X 12" Roll Splint, Lightning X 18" Roll Splint, Lightning X 2" Cloth Medical Tape and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Repackager or relabeleraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Repackager or relabeleraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Repackager or relabeleraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Repackager or relabeleraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Cylinder, Compressed Gas, And ValveECX1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYURepackager or relabeleraccessdata.fda.gov
Kit, First Aid, TalkingOVR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, BreathingBYP1Repackager or relabeleraccessdata.fda.gov
Orthosis, CervicalIQK1Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBURepackager or relabeleraccessdata.fda.gov
Pad, EyeHMP1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Repackager 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
April 4, 2024K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)LZASubstantially EquivalentHebei Titans Hongsen Medical Technology Co., Ltd.accessdata.fda.gov
February 10, 2022K211570Zeolite Hemostatic GauzeQSYSubstantially EquivalentHangzhou Zeo-Innov Life Technology Co., Ltd.accessdata.fda.gov
August 26, 2021K210288Disposable Manual ResuscitatorBTMSubstantially EquivalentXiamen Compower Medical Tech. Co., Ltd.accessdata.fda.gov
March 22, 2021K202009Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026FLLSubstantially EquivalentShenzhen Juzhong Technology Co., Ltd.accessdata.fda.gov
April 22, 2016K160019U80 Series Upper Arm Electronic Blood Pressure MonitorDXNSubstantially EquivalentShenzhen Urion Technology Co., Ltd.accessdata.fda.gov
December 7, 2012K120502PC-60NW FINGERTIP OXIMETERDQASubstantially EquivalentShenzhen Creative Industry Co., Ltd.accessdata.fda.gov
August 15, 2008K081951ANEROID SPHYGMOMANOMETER, MODEL KT-A01DXQSubstantially EquivalentWenzhou Kindcare Import & Export Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 4, 2024. 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.