FDA.reportPublic FDA data

Walkasins

Primary DI
00850004761069
Brand
Walkasins
Company
RxFunction, Inc.
Model
W-100
Catalog number
FP-10002
Device description
Foot Pad, Small Pair
Published
2019-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISWAssembly, Knee/Shank/Ankle/Foot, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004761069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004761069008500047610698500047610690850004761069

GMDN Terms#

Term, Definition table
TermDefinition
Dynamic-response foot prosthesisAn artificial substitute for a foot designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is available in a variety of designs (e.g., it may resemble the form of a natural foot, or have a split-toe design) and its construction is intended to enable the store and release of energy during the walking cycle to provide a sense of push-off and a more normal gait range. A dynamic-response foot is typically intended for an active and responsive patient to help increase activity level (e.g., vary walking speed, change direction quickly, walk long distances).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-382-3518customerservice@rxfunction.com

Regulatory Flags#

DUNS number
963353821
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
00850004761007WalkasinsW-100FP-100032019-06-21
00850004761014WalkasinsW-100PA-300042019-06-21
00850004761021WalkasinsW-100LU-200162019-06-21
00850004761045WalkasinsW-100W-100-012019-06-21
00850004761052WalkasinsW-100W-100-022019-06-21
00850004761038WalkasinsW-100W-100-Demo2019-06-20
00850004761076WalkasinsW-100LU-20016-DEMO2019-06-24
00850004761083WalkasinsW-100FP-10050-DEMO2019-06-24
00850004761090WalkasinsW-100FP-10051-DEMO2019-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04032767811571BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767811588BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767832842EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767832866EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838882EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838899EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838905EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838912EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838929EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838936EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838943EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838950EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838967EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838974EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838981EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838998EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839001EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839018EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839025EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839032EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839049EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839056EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839063EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839070EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839087EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839094EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839100EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839117EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839124EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839131EmpowerOTTO BOCK HEALTHCAREISW2018-04-11