Darco® OrthoWedge™ Pediatric
PED Black Square-toe
51manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (16), Fujian (13), Anhui (4). 10 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 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Fengtai County Guqiao Town Changxing Shoe Factory | Huainan | Anhui | Contract manufacturer | 6 |
| Ningbo NEW Nature Bath Articles Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 6 |
| Guangzhou Lead Fair Plastic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Wenzhou First Light Industry Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Apex Viet NAM Footwear Company Limited | Putian | Fujian | Contract manufacturer | 1 |
| Phuong Linh Trading Services AND Production Company Limited | Putian | Fujian | Contract manufacturer | 1 |
| Qingtian Aaron’s Footwear Co., Ltd. | Wenxi, Qingtian | Zhejiang | Contract manufacturer | 1 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
Showing 12 of 51. All 51 manufacturers in China registered for Orthosis, Corrective Shoe
Record
| Listed by | Darco International, Inc., United States |
|---|---|
| FDA product code | KNP |
| Device type | Orthosis, Corrective Shoe |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 36, box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OW-PED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD Orthopaedics | MD Orthopaedics | 350 |
| Darco® GentleStep™ Shoe | Darco International, Inc. | 66 |
| Mitchell Ponseti® Bracing System | MD Orthopaedics | 59 |
| Pogo™ Pulsus | Darco International, Inc. | 51 |
| Position Health® Classic Post-Op Shoe | Position Health, LLC | 48 |
| Procare | DJO, LLC | 42 |
| Orthosis, Corrective Shoe | Tetra Medical Supply Corp. | 42 |
| Ponseti® Lite | MD Orthopaedics | 32 |
| Vive | Vive Health LLC | 27 |
| Vivesole | Vive Health LLC | 21 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 18 |
| Darco® Medical-surgical shoe | Darco International, Inc. | 17 |
Showing 12 of 135. All products under Orthosis, Corrective Shoe
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.