FDA.reportPublic FDA data

Cadense

Primary DI
00810195430571
Brand
Cadense
Company
Cadense, Inc.
Model
AERIO Women's R1
Device description
Cadense AERIOs are adaptive sandal-slide hybrids designed to help with walking difficulties in a warm-weather format. Built with the same Variable Friction Technology as the Cadense Originals, they support smoother movement and greater ease on multiple surfaces. AERIOs feature a removable backstrap, adjustable front closure, and a supportive sole engineered for daily comfort. This versatile style offers an accessible option for those seeking adaptable footwear without compromising on functionality or design.
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810195430571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810195430571008101954305718101954305710810195430571

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
805-225-7765support@cadense.com

Regulatory Flags#

DUNS number
119535700
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810195430755CadenseHavena Women's R12025-08-18
00810195430557CadenseOriginal Men's R32025-07-08
00810195430564CadenseOriginal Women's R32025-07-08
00810195430588CadenseAERIO Men's R12025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178886319CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886326CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886333CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886340CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886357CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886364CoreTechVIVE HEALTH LLCKNP2026-02-03
00810060888582Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888599Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888605Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
06978785665087InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
06978785665094InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
00810195430755CadenseCadense, Inc.KNP2025-08-18
06978785665025InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-07-09
10810178880161ViveVIVE HEALTH LLCKNP2025-07-08
10810178880178ViveVIVE HEALTH LLCKNP2025-07-08
10810178880185ViveVIVE HEALTH LLCKNP2025-07-08
10810178880192ViveVIVE HEALTH LLCKNP2025-07-08
10810178880208ViveVIVE HEALTH LLCKNP2025-07-08
00810195430557CadenseCadense, Inc.KNP2025-07-08
00810195430564CadenseCadense, Inc.KNP2025-07-08
00810195430588CadenseCadense, Inc.KNP2025-07-08
00609271120167POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120174POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120181POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120198POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120204POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120211POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120228POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120235POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120242POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15