FDA.report

HEELIFT AFO®

Primary DI
G0648317270082040
Brand
HEELIFT AFO®
Company
POSITION HEALTH, LLC
Model
831727008204
Catalog number
831727008204
Device description
HEELIFT AFO® Suspension Boot, Heel Protector, Impact Protector, Semi-rigid splint, Non-slip Traction Sole, Convoluted Foam. Size Standard.
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G0648317270082040PrimaryHIBCC0

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

Contacts

PhoneEmail
1-800-254-5438info@positionhealthusa.com

Regulatory Flags

DUNS number
116685742
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
G064108317270090000ELBOWLIFT®10831727009000108317270090002022-12-09
G064108317270093210HEELIFT® TRACTION10831727009321108317270093212022-12-09
G064208317270091511CastWedge™20831727009151208317270091512022-12-09
G064208317270092051CastWedge™20831727009205208317270092052022-12-09
G064208317270092501CastWedge™ 20831727009250208317270092502022-12-09
G064208317270093041CastWedge™20831727009304208317270093042022-12-09
G064208317270097860HEELIFT® 20831727009786208317270097862022-12-09
G0648317270013731TurnAssist®8317270013738317270013732022-12-09
G0648317270013970TurnAssist®8317270013978317270013972022-12-09
G0648317270016631ULNAR NERVE PROTECTOR8317270016638317270016632022-12-09
G0648317270038580HEELIFT GLIDE® 8317270038588317270038582022-12-09
G0648317270041140HEEL/ELBOW PROTECTOR8317270041148317270041142022-12-09
G0648317270046640KNEE SEPARATOR8317270046648317270046642022-12-09
G0648317270052030HEELIFT GLIDE® Ultra8317270052038317270052032022-12-09
G0648317270053020HEELIFT AFO® Ultra 8317270053028317270053022022-12-09
G0648317270054010HEELIFT GLIDE® Ultra8317270054018317270054012022-12-09
G0648317270055000HEELIFT GLIDE® Ultra8317270055008317270055002022-12-09
G0648317270062790HEELIFT GLIDE® 8317270062798317270062792022-12-09
G0648317270064530HEELIFT GLIDE® 8317270064538317270064532022-12-09
G0648317270064600HEELIFT GLIDE® 8317270064608317270064602022-12-09

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