FDA Registration
Active
🇺🇸 United States
ENCOMPASS GROUP, LLC.
Reg #: 1043644
·
FEI: 1043644
·
Expires 2026
Products
25
Proprietary Names
8
Establishment Types
5
Classifications
25
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Registration Details
- Registration Name
- ENCOMPASS GROUP, LLC.
- Registration Number
- 1043644
- FEI Number
- 1043644
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 615 Macon Street
- City
- McDonough
- State
- GA
- ZIP
- 30253
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982059
Owner / Operator
- Firm Name
- ENCOMPASS GROUP, LLC.
- Operator Number
- 1043644
- Address
- 615 Macon Street, --
- City
- McDonough
- State
- GA
- Postal Code
- 30253
- Country
- US
- Correspondent
- Jessica Lester
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2007-11-30 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2011-04-01 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2023-03-23 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2023-03-23 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 1992-10-23 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2020-08-27 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2020-12-15 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2009-03-02 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-03-10 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2017-10-11 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 1977-12-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 1992-10-23 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2017-10-11 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-05-17 |
| Bed, Patient Rotation, Powered | IKZ | Class 2 | Physical Medicine | No | 2019-03-18 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2013-06-28 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2013-06-28 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2013-09-05 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-12-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2007-11-30 |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | Class 2 | General, Plastic Surgery | No | 2020-02-17 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2023-03-23 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2013-06-28 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2013-06-28 |
Proprietary Names
AlbaHealth Anti-Embolism Stockings
Albahealth Impervious Stockinette
NOVA Patient Warming System
Encompass Group LLC
Encompass Group
The Pillow Factory Inc
AlbaHealth C.A.R.E. Anti-Embolism Stockings
Encompass Group, LLC.
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)