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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Specification developer | accessdata.fda.gov |
| Bed, Patient Rotation, Powered | IKZ | 2 | Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Binder, Breast | HEF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Drape, Adhesive, Aerosol | KGT | 1 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2020 | K203085 | NOVA Patient Warming System | DWJ | Substantially Equivalent | Encompass Group, LLC | accessdata.fda.gov |
| July 7, 2017 | K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | QPC | Substantially Equivalent | Bam Corporation Limited | accessdata.fda.gov |
| November 17, 2005 | K052169 | IMC SURGICAL DRAPES | KKX | Substantially Equivalent | International Medsurg Connection, Inc. | accessdata.fda.gov |
| January 14, 1999 | K982058 | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN | FYA | Substantially Equivalent | Encompass Group, LLC | accessdata.fda.gov |
| November 30, 1998 | K982059 | ROTECNO 2000 SURGICAL GOWN | FYA | Substantially Equivalent | Encompass Group, LLC | accessdata.fda.gov |
| October 11, 1991 | K913506 | CONVERTORS SAFECARE GOWN & DRAPE MATERIAL | KKX | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 18, 1979 | K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | KKX | Substantially Equivalent | Alba-Waldensian, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 23, 2009 | 54134 | Not yet classified | Terminated | Thermoflect 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
- All makers of Bandage, Cast
- All makers of Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- All makers of Non-Surgical Gown
- All makers of Drape, Surgical, Antimicrobial
- All makers of Device, Transfer, Patient, Manual
- All makers of Instrument, Manual, Surgical, General Use
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.