Podoactiva
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…
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.
Who Else Makes It
Concentrated in Guangdong (13), Zhejiang (6), Shanghai (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Guangzhou Lead Fair Plastic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
| Suzhou Sunmed Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 28 |
Showing 12 of 34. All 34 manufacturers in China registered for Insoles, Medical
Record
| Listed by | Instituto DE Investigacion EN Ortopedia Avanzada Sociedad Limitada. |
|---|---|
| FDA product code | KYS |
| Device type | Insoles, Medical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6280 |
| Premarket notification | Exempt |
| Record published | 2023-10-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature up to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PODOACTIVA-US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Estcarbon | Erismet OU | 172 |
| Relief+ | Solo Laboratories | 36 |
| ViveSole | Vive Health LLC | 31 |
| Hapad Comf-Orthotic Wool Felt Full Length Insole | Hapad, Inc | 22 |
| Hapad Comf-Orthotic 3/4 Length Wool Felt Insole | Hapad, Inc | 21 |
| Hapad Comf-Orthotic Extra Cushioning Insoles | Hapad, Inc | 20 |
| Hapad Comf-Orthotic PRO Blue Insoles | Hapad, Inc | 16 |
| Hapad Heel Lifts | Hapad, Inc | 15 |
| Donjoy Performance | DJO, LLC | 14 |
| Comforsil | Prim,s.a. | 13 |
| Procare | DJO, LLC | 12 |
| 2 Pack Accommodator Semi Rigid PRO FL | Alimed, LLC | 11 |
Showing 12 of 141. All products under Insoles, Medical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.