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Podoactiva

FDA UDI

Class I (US FDA UDI)

by Instituto De Investigacion En Ortopedia Avanzada Sociedad Limitada.

Identity

Trade Name
Podoactiva FDA UDI
Generic Name
Orthotic insole, custom-made FDA UDI
Device Name
Orthopedic and personalized Podoactiva insoles are classified as Class I medical devices intended to prevent and treat various foot-related pathologies. These insoles are custom-made for each patient. They comprise an insole body created through 3D printing, following the prior capture of a virtual mold of the foot using a scanner. This process enables the design of an optimal and personalized treatment plan for the patient. Subsequently, the insole body is covered with a lining to enhance comfort and achieve a polished finish. These insoles are recommended as a treatment option with a medical prescription for individuals dealing with various foot pathologies or related issues such as injuries, discomfort from an irregular foot structure, age-related problems, or biomechanical abnormalities affecting the spine, hips, and knees. Therefore, orthopedic custom insoles are designed to correct and alleviate abnormalities in the arch of the foot, ultimately improving one's gait and helping to prevent injuries. FDA UDI
Model / Reference
PODOACTIVA-US FDA UDI
Description
Orthopedic and personalized Podoactiva insoles are classified as Class I medical devices intended to prevent and treat various foot-related pathologies. These insoles are custom-made for each patient. They comprise an insole body created through 3D printing, following the prior capture of a virtual mold of the foot using a scanner. This process enables the design of an optimal and personalized treatment plan for the patient. Subsequently, the insole body is covered with a lining to enhance comfort and achieve a polished finish. These insoles are recommended as a treatment option with a medical prescription for individuals dealing with various foot pathologies or related issues such as injuries, discomfort from an irregular foot structure, age-related problems, or biomechanical abnormalities affecting the spine, hips, and knees. Therefore, orthopedic custom insoles are designed to correct and alleviate abnormalities in the arch of the foot, ultimately improving one's gait and helping to prevent injuries. FDA UDI

Identifiers

Primary DI / UDI-DI
08437026597009 FDA UDI
FDA Product Code
KYS FDA UDI
GMDN Term
Orthotic insole, custom-made FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6280 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthotic insole, custom-made

Podoactiva by Instituto De Investigacion En Ortopedia Avanzada Sociedad Limitada. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthotic insole, custom-made.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instituto De Investigacion En Ortopedia Avanzada Sociedad Limitada.

Sources (1)

  • FDA UDI 3009a042-ae40-4381-bcea-4d4e7bcde178 35 fields · synced May 30, 2026