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…

Registry build 21.09.26

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.

34manufacturers in China registered for this device type
1catalogue number

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.

Chinese manufacturers registered for FDA product code KYS
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

Regulatory record for Podoactiva
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

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 numbers for Podoactiva
Catalogue number Size Status
PODOACTIVA-US In distribution

Same Product Code

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer