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

Breg, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 4 510(k) clearances

Breg, Inc. is registered with the FDA (registration 3010694026) in Indianapolis, IN, United States. It lists 33 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 21, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Breg, Inc.
FDA registration number
3010694026
Address
2835 Fortune Cir W, Indianapolis, IN, United States, 46241
Owner or operator
Breg Inc (10041297)
Roles
Repackager or relabeler
First device listed
July 10, 2012
Registered through
2026
Brand names listed
20.50 Patellofemoral, ABDUCTION PILLOW CONTOURED, ADJ DONUT, ADJ NIGHT SPLINT, ALIGNER PHX, ARC DYNAMIC, Abdominal Binder, Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads and more

Devices it lists

DeviceProduct codeClassRoleSource
Bag, IceKYR1Repackager or relabeleraccessdata.fda.gov
Binder, AbdominalFSD1Repackager or relabeleraccessdata.fda.gov
CaneIPS1Repackager or relabeleraccessdata.fda.gov
Components, ExerciseIOD1Repackager or relabeleraccessdata.fda.gov
Cover, LimbIPM1Repackager or relabeleraccessdata.fda.gov
CrutchIPR1Repackager or relabeleraccessdata.fda.gov
Cushion, FlotationKIC1Repackager or relabeleraccessdata.fda.gov
Insoles, MedicalKYS1Repackager or relabeleraccessdata.fda.gov
Joint, Ankle, External BraceITW1Repackager or relabeleraccessdata.fda.gov
Joint, Hip, External BraceITS1Repackager or relabeleraccessdata.fda.gov
Joint, Knee, External BraceITQ1Repackager or relabeleraccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Repackager or relabeleraccessdata.fda.gov
Orthosis, AbdominalKTD1Repackager or relabeleraccessdata.fda.gov
Orthosis, CervicalIQK1Repackager or relabeleraccessdata.fda.gov
Orthosis, Limb BraceIQI1Repackager or relabeleraccessdata.fda.gov
Orthosis, LumbarIQE1Repackager or relabeleraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Repackager or relabeleraccessdata.fda.gov
Orthosis, Rib Fracture, SoftIPX1Repackager or relabeleraccessdata.fda.gov
Orthosis, ThoracicIPT1Repackager or relabeleraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Repackager or relabeleraccessdata.fda.gov
Shoe, CastIPG1Repackager or relabeleraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Repackager or relabeleraccessdata.fda.gov
Splint, ClavicleIQJ1Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Splint, Temporary TrainingIQM1Repackager or relabeleraccessdata.fda.gov
Support, ArmIOY1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tape, OrthopedicHXT1Repackager or relabeleraccessdata.fda.gov
Walker, MechanicalITJ1Repackager 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
January 21, 2021K202839Overlapped Compression TherapyJOWSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
March 1, 2019K183702Polar Care WaveIRPSubstantially EquivalentBreg, Inc.accessdata.fda.gov
February 22, 2013K122640VPULSEJOWSubstantially EquivalentCothera, LLCaccessdata.fda.gov
October 24, 1991K914434POLAR PADSILOSubstantially EquivalentBreg, Inc.accessdata.fda.gov

Compare with other makers

Updated January 21, 2021. 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.