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Data / Medical devices / United States / Encompass Group, LLC.

Encompass Group, LLC.: FDA-registered device maker in McDonough, GA, United States, 7 510(k) clearances

Encompass Group, LLC. is registered with the FDA (registration 1043644) in McDonough, GA, United States. It lists 25 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 12, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
1043644
Address
615 Macon Street, McDonough, GA, United States, 30253
Owner or operator
ENCOMPASS GROUP, LLC. (1043644)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 23, 1977
Registered through
2027
Brand names listed
AlbaHealth Anti-Embolism Stockings, AlbaHealth C.A.R.E. Anti-Embolism Stockings, Albahealth Impervious Stockinette, Encompass Group, Encompass Group LLC, Encompass Group, LLC., NOVA Patient Warming System, The Pillow Factory Inc

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Bandage, CastITG1Specification developeraccessdata.fda.gov
Bed, Patient Rotation, PoweredIKZ2Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Complaint file establishment, Specification developeraccessdata.fda.gov
Binder, BreastHEF1Complaint file establishment, Specification developeraccessdata.fda.gov
Binder, Medical, TherapeuticMDR1Complaint file establishment, Specification developeraccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Complaint file establishment, Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Complaint file establishment, Specification developeraccessdata.fda.gov
Drape, Adhesive, AerosolKGT1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Complaint file establishment, Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufacturer, Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Complaint file establishment, Specification developeraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Complaint file establishment, Specification developeraccessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionQPC2Manufacturer, Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Complaint file establishment, Specification developeraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Thermal RegulatingDWJ2Manufacturer, Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Complaint file establishment, Specification developeraccessdata.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
November 12, 2020K203085NOVA Patient Warming SystemDWJSubstantially EquivalentEncompass Group, LLCaccessdata.fda.gov
July 7, 2017K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsQPCSubstantially EquivalentBam Corporation Limitedaccessdata.fda.gov
November 17, 2005K052169IMC SURGICAL DRAPESKKXSubstantially EquivalentInternational Medsurg Connection, Inc.accessdata.fda.gov
January 14, 1999K982058ROTECNO FR (FLUID RESISTANT) SURGICAL GOWNFYASubstantially EquivalentEncompass Group, LLCaccessdata.fda.gov
November 30, 1998K982059ROTECNO 2000 SURGICAL GOWNFYASubstantially EquivalentEncompass Group, LLCaccessdata.fda.gov
October 11, 1991K913506CONVERTORS SAFECARE GOWN & DRAPE MATERIALKKXSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
December 18, 1979K792357STERILE IMPERVIOUS ORTHOPEDIC STOCKINKKXSubstantially EquivalentAlba-Waldensian, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 23, 200954134Not yet classifiedTerminatedThermoflect Product Line including items for adults and pediatrics.The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.accessdata.fda.gov

Compare with other makers

Updated November 12, 2020. 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.