FDA.report

EVO Ankle Stabilizer

Primary DI
00802357640928
Brand
EVO Ankle Stabilizer
Company
MEDICAL SPECIALTIES INCORPORATED
Model
264092
Published
2022-12-07
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
false

Related Records

Product Codes

CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications

CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00802357640928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357640928008023576409288023576409280802357640928

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
003173028
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

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00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357236411ASO Speed Lacer II Ankle Stabilizer w/Stays2236412025-05-06
00802357236428ASO Speed Lacer II Ankle Stabilizer w/Stays2236422025-05-06
00802357236442ASO Speed Lacer II Ankle Stabilizer w/Stays2236442025-05-06
00802357236459ASO Speed Lacer II Ankle Stabilizer w/Stays2236452025-05-06
00802357236466ASO Speed Lacer II Ankle Stabilizer w/Stays2236462025-05-06
00802357236473ASO Speed Lacer II Ankle Stabilizer w/Stays2236472025-05-06
00802357172313Gripper 3 Knee, 12" CoolFlex1172312025-01-14
00802357172320Gripper 3 Knee, 12" CoolFlex1172322025-01-14
00802357172344Gripper 3 Knee, 12" Coolflex1172342025-01-14
00802357172351Gripper 3 Knee, 12" Coolflex1172352025-01-14
00802357172368Gripper 3 Knee, 12" Coolflex1172362025-01-14
00802357172375Gripper 3 Knee, 12" Coolflex1172372025-01-14
00802357172382Gripper 3 Knee, 12" Coolflex1172382025-01-14
00802357172399Gripper 3 Knee, 12" Coolflex1172392025-01-14
00802357234400EPIGEL W/STAYS, UNIVERSAL2234402025-01-14
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

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
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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