ENCOMPASS GROUP, LLC.

FDA Device Registration & Listing · McDonough, GA, US · Registration 1043644

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1043644
FEI Number
1043644
Entity Name
ENCOMPASS GROUP, LLC.
City/State/Country
McDonough, GA, US
Establishment Address
615 Macon Street, McDonough, GA 30253, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ENCOMPASS GROUP, LLC. (Owner Number: 1043644)
Owner / Operator Contact Address
615 Macon Street, --, McDonough, GA 30253, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AlbaHealth Anti-Embolism Stockings Albahealth Impervious Stockinette NOVA Patient Warming System Encompass Group LLC Albahealth Impervious Stockinette Encompass Group The Pillow Factory Inc

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-30
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-30
FME Gown, Examination General Hospital Class 1 880.6265 2011-04-01
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2023-03-23
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2023-03-23
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 1992-10-23
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-03-30
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-11-30
KGT Drape, Adhesive, Aerosol General, Plastic Surgery Class 1 878.4380 2020-08-27
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2020-12-15
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2009-03-02
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2014-03-10
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-03-23
FNM Mattress, Air Flotation, Alternating Pressure General Hospital Class 2 880.5550 2017-10-11
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 1977-12-23
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 1992-10-23
IKY Mattress, Flotation Therapy, Non-Powered General Hospital Class 1 880.5150 2017-10-11
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2012-05-17
IKZ Bed, Patient Rotation, Powered Physical Medicine Class 2 890.5225 2019-03-18
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2013-06-28
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2013-06-28
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2013-09-05
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-12-08
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2007-11-30

Official Correspondent

Jessica Lester

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENCOMPASS GROUP, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 2017-10-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043644. Last updated year: 2026. Please use registration number 1043644 when referencing this establishment in official correspondence.
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