FDA.report

DARCO® Body Armor® Embrace

Primary DI
25060634180010
Brand
DARCO® Body Armor® Embrace
Company
DARCO INTERNATIONAL, INC.
Model
EB1B-R
Catalog number
EB1B-R
Device description
Small Black Right
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ITWJOINT, ANKLE, EXTERNAL BRACE

Product Code Classifications

CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060634180013PackageGS14In Commercial Distribution
25060634180010PackageGS112In Commercial Distribution
05060634180016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1506063418001315060634180013
2506063418001025060634180010
05060634180016050606341800165060634180016

GMDN Terms

TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16974500613446Ankle SupportGCMEDICA ENTERPRISE LTD.(WUXI)ITW2025-12-08
00810113682891ManaEZ Ankle 06 Extra SmallManamed, Inc.ITW2025-09-26
00810113682907ManaEZ Ankle 06 SmallManamed, Inc.ITW2025-09-26
00810113682914ManaEZ Ankle 06 MediumManamed, Inc.ITW2025-09-26
00810113682921ManaEZ Ankle 06 LargeManamed, Inc.ITW2025-09-26
00810113682938ManaEZ Ankle 06 Extra LargeManamed, Inc.ITW2025-09-26
00810113682945ManaEZ Ankle 06 Extra Extra LargeManamed, Inc.ITW2025-09-26
00810113683126ManaEZ Night Splint, Plantar Fasciitis, SmallManamed, Inc.ITW2025-09-26
00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
00810113683324ManaGO71 Ankle Brace Extra LargeManamed, Inc.ITW2025-09-26
00810113683331ManaGO71 Ankle Brace LargeManamed, Inc.ITW2025-09-26
00810113683348ManaGO71 Ankle Brace MediumManamed, Inc.ITW2025-09-26
00810113683355ManaGO71 Ankle Brace SmallManamed, Inc.ITW2025-09-26
00749756399333DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399340DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399357DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399364DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399371DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00190446662563PROCAREDJO, LLCITW2025-07-10
00190446662570PROCAREDJO, LLCITW2025-07-10
00190446662587PROCAREDJO, LLCITW2025-07-10
00190446662594PROCAREDJO, LLCITW2025-07-10
00190446662600PROCAREDJO, LLCITW2025-07-10
00819567011660ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017853ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017860ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017877ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017884ComfytopiaComfytopia, Inc.ITW2025-07-09
00854194003121ComfytopiaComfytopia, Inc.ITW2025-07-09