Encompass Group, LLC
United States US-MF-000008638 Last updated 21 Oct 2026
- Devices
- 14
- Registries
- EUDAMEDGUDIDFDA 510(k)
- FDA recalls
- 1
Catalogue
Thermoflect Blanket Ref 5100-200
Thermoflect Blanket Ref 5100-700
Thermoflect Patient Gown Ref 5145-500
Rotecno Fr (Fluid Resistant) Surgical Gown Ref K982058
Patient Restraint Ref K760618
NOVA Patient Warming System Ref K203085
Rotecno 2000 Surgical Gown Ref K982059
Thermoflect Cap Ref 5110-100
Thermoflect Leggings Ref 5120-350
Thermoflect Pulse Oximeter Mitt Ref 5105-100
Thermoflect Papoose Ref 5100-250
Thermoflect Blanket Ref 5100-400
Thermoflect Adult Transport Cocoon Ref 5170-200
Thermoflect Blanket Kit, Medium Ref 5200-400
Related companies
Authorised representatives
FDA recalls
Encompass Group, LLC has one FDA recall record initiated on December 23, 2009, which is marked as terminated. The recall was due to products not being compatible for use in the Magnetic Resonance Imaging (MRI) environment.
2009
- 23 Dec 2009 Z-1175-2010 Unclassified (pre-2012) Terminated The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.
About
Encompass Group is a leading manufacturer and marketer of textiles, apparel, therapeutic support services, and single-use medical products.
What Encompass Group, LLC makes
The company manufactures single-use and reusable patient warming solutions, including blankets, gowns, and apparel designed for temperature regulation, such as the Thermoflect Blanket, Thermoflect Patient Gown, and Thermoflect Leggings. It also produces surgical gowns with fluid-resistant properties, like the ROTECNO FR and ROTECNO 2000 models, as well as patient restraints and accessories like pulse oximeter mitts and neonatal swaddling devices. Additional offerings include a patient warming system, the NOVA System, and protective headwear like the Thermoflect Cap.
These products are classified under FDA’s Class I and Class II categories, with some devices listed in the EU’s EUDAMED database and others subject to FDA’s 510(k) clearance process. The company’s devices are regulated under US and EU medical device frameworks, ensuring compliance with applicable safety and performance standards. The manufacturer operates from the United States.
Information
- Country
- United States
- Address
- 615, Macon Street, McDonough, United States
- Website
- www.encompassgroup.com
- facebook.com/EncompassGrpLLC
- [email protected]
- Phone
- 770 626 2172
- PRRC contact
- Jessica Lester
- EUDAMED SRN
- US-MF-000008638