FDA.reportPublic FDA data

Walkasins

Primary DI
00850004761151
Brand
Walkasins
Company
RxFunction, Inc.
Model
W-100
Catalog number
W-100-06
Device description
Unilateral System, Small Right
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850004761151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004761151008500047611518500047611510850004761151

GMDN Terms#

Term, Definition table
TermDefinition
Foot sensorimotor therapy mechanical neurostimulatorAn electrically-powered device intended to be used in a clinical setting and in the home to provide noninvasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders (e.g., Parkinson's disease). It is designed as an electromechanical apparatus with metal actuators which apply pressure stimuli to specific areas of the feet during regular therapeutic sessions.

Contacts#

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

Regulatory Flags#

DUNS number
963353821
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004761106WalkasinsW-100FP-101522026-06-24
00850004761113WalkasinsW-100FP-101532026-06-24
00850004761120WalkasinsW-100FP-101602026-06-24
00850004761137WalkasinsW-100FP-101612026-06-24
00850004761144WalkasinsW-100W-100-052026-06-24
00850004761168WalkasinsW-100W-100-072026-06-24
00850004761175WalkasinsW-100W-100-082026-06-24
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
00850004761069WalkasinsW-100FP-100022019-06-21
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
00850004761106WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761113WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761120WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761137WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761144WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761168WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761175WalkasinsRxFunction, Inc.ISW2026-06-24
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