Podoactiva

GUDID 08437026597009

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.

INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA.

Orthotic insole, custom-made

• Primary Device ID: 08437026597009
• NIH Device Record Key: 3009a042-ae40-4381-bcea-4d4e7bcde178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Podoactiva
• Version Model Number: PODOACTIVA-US
• Company DUNS: 469534003
• Company Name: INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com
• Phone: +34974231280
• Email: info@podoactiva.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437026597009 [Primary]

FDA Product Code

• KYS: Insoles, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-26
• Device Publish Date: 2023-10-18