FDA.report

Easy Step

Primary DI
G505MRES0
Brand
Easy Step
Company
M.A.S.S. Rehab, LLC
Model
Standard
Device description
Device to help lift foot during walking.
Published
2023-08-01
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
OHIOrthosis, Foot Drop

Product Code Classifications

CodeDeviceSpecialtyClass
OHIOrthosis, Foot DropPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G505MRES0PrimaryHIBCC0

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
603101416
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
G505MRBHS0Balance Harness Standard2023-08-01
G505MRHSH0Healing Solutions HarnessStandard2023-08-01
G505MRMS0M.A.S.S. StrapStandard2023-08-01
G505MRPH0Pediatric HarnessStandard2023-08-01
G505MRST0Slip TrainerStandard2023-08-01
G505MRTB0M.A.S.S. Traction BeltStandard2023-08-01
G505MRUHB0Unloading Harness BariatricBariatric2023-08-01
G505MRUHS0Unloading HarnessStandard2023-08-01

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