Podoactiva
Basic Information
- Brand Name
- Podoactiva
- Primary DI
- 08437026597009
- Version / Model
- PODOACTIVA-US
- Company Name
- INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA.
- Labeler DUNS
- 469534003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-18
- Public Version
- 1
- Public Version Date
- 2023-10-26
- Public Version Status
- New
- Public Device Record Key
- 3009a042-ae40-4381-bcea-4d4e7bcde178
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYS | Insoles, Medical | General Hospital | 880.6280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62870 | Orthotic insole, custom-made | A shoe insert intended to provide supplemental support for the sole, arch, and/or heel of the foot and specifically produced to meet an individual's special requirements, having been prescribed by a relevant healthcare professional. It is made of various materials (e.g., cork, rubber, foam, textile) and may be of modular design by assembly of various pre-made components. This is a reusable device intended for single-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437026597009 | GS1 |
Customer Contacts
- Phone
- +34974231280
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius