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Data / Medical devices / United States / Faretec, Inc.

Faretec, Inc.: FDA-registered device maker in Painesville, OH, United States, 1 510(k) clearance

Faretec, Inc. is registered with the FDA (registration 1528440) in Painesville, OH, United States. It lists 22 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 1978. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Faretec, Inc.
FDA registration number
1528440
FEI number
1000122527
Address
1610 W. JACKSON ST. No. 6, Painesville, OH, United States, 44077
Owner or operator
FARETEC, INC. (9004548)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
November 18, 1992
Registered through
2026
Brand names listed
Airway Tube, CT-6 Traction Splint, Chest Seal, Bolin Chest Seal, Occlusive Dressing, Combat Tape, Compression Bandage, Compression Gauze, Cric Kit, EL3000/EL2000 Litter Carrier and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
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
Cricothyrotomy KitOGP2Manufacturer for exportaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Repackager or relabeleraccessdata.fda.gov
Orthosis, Sacroiliac, SoftIPW1Manufactureraccessdata.fda.gov
Protector, Hearing (Insert)EWDURepackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Splint, TractionHSP1Manufactureraccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Repackager or relabeleraccessdata.fda.gov
Stretcher, Patient RestraintNZD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Stretcher, WheeledFPO2Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager 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
September 27, 1978K781491PRO-MOLD, CUSTOM EAREWDSubstantially EquivalentMcghan Medical Corp.accessdata.fda.gov

Compare with other makers

Updated September 27, 1978. 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.