FDA.reportPublic FDA data

Position Health® Classic Post-Op Shoe

Primary DI
G0648317270027520
Brand
Position Health® Classic Post-Op Shoe
Company
POSITION HEALTH, LLC
Model
831727002752
Device description
Position Health® Classic Ankle High Square Toe Post-Op Shoe. Color-Black. Size-X-Small.
Published
2024-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPGShoe, Cast
KNPOrthosis, Corrective Shoe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0648317270027520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cast shoe, single-useA footwear designed to be worn over a foot that is encased in a cast in order to protect the cast material and add stability for the patient while ambulating. Its foot bed provides comfort when ambulating and it may or may not protect the toes. It is available in a variety of designs and sizes and can be typically used both indoors and outdoors; some types may be used without a cast, e.g., in the case of a toe fracture. This is a disposable device that is intended for a single-patient use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-254-5438info@walgreenhealthsolutions.com
1-800-254-5438info@positionhealthusa.com

Regulatory Flags#

DUNS number
116685742
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0648317270013971TurnAssist®8317270013978317270013972022-12-09
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

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