Encompass Group LLC
McDonough, GA, US
ENCOMPASS GROUP, LLC. appears in FDA device records in McDonough, GA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Encompass Group LLC between 1976 and 2020. The busiest year on record is 1976, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203085 | NOVA Patient Warming System | DWJ | Substantially Equivalent | |
| K982058 | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN | FYA | Substantially Equivalent | |
| K982059 | ROTECNO 2000 SURGICAL GOWN | FYA | Substantially Equivalent | |
| K760618 | PATIENT RESTRAINT | FMQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1043644 | 1043644 | ENCOMPASS GROUP, LLC. | 615 Macon Street, McDonough, GA 30253 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- ITGBandage, Cast
- IKZBed, Patient Rotation, Powered
- KMEBedding, Disposable, Medical
- HEFBinder, Breast
- MDRBinder, Medical, Therapeutic
- FMWCover, Mattress (Medical Purposes)
- FMRDevice, Transfer, Patient, Manual
- KGTDrape, Adhesive, Aerosol
- KKXDrape, Surgical, Antimicrobial
- PUIDrape, Surgical, Exempt
- FRLFiber, Medical, Absorbent
- EYQGarment, Protective, For Incontinence
- FMEGown, Examination
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- FYAGown, Surgical
- MDMInstrument, Manual, Surgical, General Use
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- OEANon-Surgical Gown
- FMPProtector, Skin Pressure
- FMQRestraint, Protective
- FQLStocking, Medical Support (For General Medical Purposes)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- DWJSystem, Thermal Regulating
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1175-2010 | Thermoflect Product Line including items for adults and pediatrics. | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain