Accent
Accent Foot, Right, Caucasian, DP 4HPA, Lateral Btn, 27cm, Narrow, Category 3
Who Else Makes It
Concentrated in Zhejiang (4), Anhui (3), Fujian (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
| Kaipeng Medical Tech Development Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 12 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
Showing 12 of 14. All 14 manufacturers in China registered for Component, External, Limb, Ankle/Foot
Record
| Listed by | College Park Industries, United States |
|---|---|
| FDA product code | ISH |
| Device type | Component, External, Limb, Ankle/Foot |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC LCDMM 28N D2 | In distribution | |
| AC RBDFM 26W D2 | In distribution | |
| AC RCIPM 27N D2 | In distribution | |
| AC RCD4M 24W D2 | In distribution | |
| AC LCD4L 26W D2 | In distribution | |
| AC LCDML 28N D1 | In distribution | |
| AC RBIPM 24W D2 | In distribution | |
| AC LCD4M 24N D1 | In distribution | |
| AC RCD4L 24W D3 | In distribution | |
| AC LBD4M 26W D2 | In distribution | |
| AC RBD4M 23N D1 | In distribution | |
| AC LCDMM 21N D2 | In distribution | |
| AC LCDFM 23W D3 | In distribution | |
| AC LCD4M 24N D2 | In distribution | |
| AC LCDFM 27N D1 | In distribution | |
| AC LCDMM 24N D3 | In distribution | |
| AC LCIPM 24W D2 | In distribution | |
| AC LBDFL 24W D3 | In distribution | |
| AC RBDML 23N D1 | In distribution | |
| AC LBDML 24W D1 | In distribution | |
| AC LBDFM 25N D3 | In distribution | |
| AC LCD4M 27N D3 | In distribution | |
| AC LCIPM 22N D1 | In distribution | |
| AC RCD4M 25N D1 | In distribution | |
| AC LBIPL 23N D1 | In distribution | |
| AC LCDFM 23W D2 | In distribution | |
| AC LCDMM 22N D3 | In distribution | |
| AC RBD4M 25W D2 | In distribution | |
| AC RBIPL 21N D2 | In distribution | |
| AC RBD4L 24N D1 | In distribution | |
| AC RCDML 23N D3 | In distribution | |
| AC LCDFL 21N D1 | In distribution | |
| AC RBIPM 24W D1 | In distribution | |
| AC LCD4M 23W D3 | In distribution | |
| AC RCIPL 26W D2 | In distribution | |
| AC RBIPM 26W D3 | In distribution | |
| AC RCDML 26W D3 | In distribution | |
| AC RBIPM 28N D3 | In distribution | |
| AC LBDFL 28N D1 | In distribution | |
| AC LCD4L 22N D2 | In distribution | |
| AC RCIPM 23N D2 | In distribution | |
| AC LCIPL 23N D3 | In distribution | |
| AC LBD4M 25N D3 | In distribution | |
| AC LBD4M 24W D2 | In distribution | |
| AC RCDMM 26N D3 | In distribution | |
| AC RBD4L 24N D3 | In distribution | |
| AC RBD4M 27N D2 | In distribution | |
| AC RBDML 24N D1 | In distribution | |
| AC LBDFM 21N D2 | In distribution | |
| AC RBDFM 25N D1 | In distribution | |
| AC LCDFM 25N D1 | In distribution | |
| AC LCDML 25N D2 | In distribution | |
| AC RBD4L 23W D1 | In distribution | |
| AC RBIPM 28N D1 | In distribution | |
| AC RBD4L 26W D2 | In distribution | |
| AC RBD4M 21N D3 | In distribution | |
| AC LBD4L 22N D2 | In distribution | |
| AC LCDML 21N D1 | In distribution | |
| AC RBD4L 23W D2 | In distribution | |
| AC LCD4L 26N D2 | In distribution | |
| AC LBD4L 24W D1 | In distribution | |
| AC RCIPM 28N D3 | In distribution | |
| AC RBDFM 23N D3 | In distribution | |
| AC RCDMM 25N D3 | In distribution | |
| AC RBIPL 24W D3 | In distribution | |
| AC LBIPM 23W D1 | In distribution | |
| AC RCDFL 23N D1 | In distribution | |
| AC RBD4M 25N D3 | In distribution | |
| AC LBD4M 26W D1 | In distribution | |
| AC RBD4M 26N D3 | In distribution | |
| AC RCDMM 26W D2 | In distribution | |
| AC RCD4L 27N D3 | In distribution | |
| AC RBD4L 21N D3 | In distribution | |
| AC LCIPL 28N D1 | In distribution | |
| AC LBDMM 26W D3 | In distribution | |
| AC RCDML 23W D1 | In distribution | |
| AC RBDML 25W D1 | In distribution | |
| AC RCIPL 26N D2 | In distribution | |
| AC LCDMM 25W D3 | In distribution | |
| AC LCIPL 25W D2 | In distribution | |
| AC RCDML 25N D2 | In distribution | |
| AC RCIPL 23W D3 | In distribution | |
| AC RCD4M 26W D2 | In distribution | |
| AC RCDML 24N D1 | In distribution | |
| AC LCDFM 24W D2 | In distribution | |
| AC LCD4M 26W D2 | In distribution | |
| AC LBDFL 26N D1 | In distribution | |
| AC LCDFM 22N D3 | In distribution | |
| AC LCDML 27N D1 | In distribution | |
| AC RCDFM 24N D3 | In distribution | |
| AC LBDML 25N D3 | In distribution | |
| AC RCDFM 24N D1 | In distribution | |
| AC LBD4M 21N D1 | In distribution | |
| AC RBDFM 27N D1 | In distribution | |
| AC LCD4M 22N D1 | In distribution | |
| AC LCD4L 25N D3 | In distribution | |
| AC LCDFL 23N D1 | In distribution | |
| AC LCDML 25W D2 | In distribution | |
| AC LBDMM 27N D1 | In distribution | |
| AC LCD4L 25W D1 | In distribution | |
| AC RBDML 24W D3 | In distribution | |
| AC LBDFL 26N D2 | In distribution | |
| AC RBD4L 25W D1 | In distribution | |
| AC LBD4L 21N D1 | In distribution | |
| AC LCDMM 26W D2 | In distribution | |
| AC LBDMM 24W D2 | In distribution | |
| AC RBDMM 23N D1 | In distribution | |
| AC LCDML 23W D1 | In distribution | |
| AC RCD4L 26W D1 | In distribution | |
| AC RCIPL 26N D1 | In distribution | |
| AC LBDFL 26W D1 | In distribution | |
| AC LCDFM 24N D1 | In distribution | |
| AC RCDFM 26N D2 | In distribution | |
| AC LBD4M 22N D2 | In distribution | |
| AC RCIPM 21N D3 | In distribution | |
| AC RBIPM 21N D2 | In distribution | |
| AC LCD4M 24W D2 | In distribution | |
| AC RCDFM 24W D2 | In distribution | |
| AC LCIPL 24N D3 | In distribution | |
| AC RCDFM 25W D2 | In distribution | |
| AC LCD4L 23N D3 | In distribution | |
| AC LCD4L 21N D2 | In distribution | |
| AC LBDMM 24W D1 | In distribution | |
| AC RCDFM 28N D3 | In distribution | |
| AC RBDMM 28N D3 | In distribution | |
| AC RCD4M 24N D3 | In distribution | |
| AC LCIPM 23W D1 | In distribution | |
| AC LCDFM 26W D1 | In distribution | |
| AC RCDMM 28N D3 | In distribution | |
| AC RBD4M 23W D3 | In distribution | |
| AC LBDFM 27N D3 | In distribution | |
| AC LCD4L 23N D1 | In distribution | |
| AC RCIPM 23W D3 | In distribution | |
| AC RCD4M 26W D1 | In distribution | |
| AC RBDML 21N D1 | In distribution | |
| AC RCDFL 28N D2 | In distribution | |
| AC LBIPL 27N D2 | In distribution | |
| AC RCDFL 28N D1 | In distribution | |
| AC LCDFM 24W D3 | In distribution | |
| AC LCIPM 22N D3 | In distribution | |
| AC RBD4L 24W D3 | In distribution | |
| AC LCDFL 21N D2 | In distribution | |
| AC RBIPM 24N D1 | In distribution | |
| AC LBDML 26W D1 | In distribution | |
| AC LCD4M 23N D3 | In distribution | |
| AC LCIPM 26W D1 | In distribution | |
| AC RCDML 28N D3 | In distribution | |
| AC RBDMM 24N D3 | In distribution | |
| AC LCIPM 25N D3 | In distribution | |
| AC RCDML 26W D2 | In distribution | |
| AC RBIPL 28N D3 | In distribution | |
| AC RBDML 22N D3 | In distribution | |
| AC LBD4L 23W D2 | In distribution | |
| AC RBD4L 26W D3 | In distribution | |
| AC LBIPL 24N D3 | In distribution | |
| AC RCDML 22N D1 | In distribution | |
| AC RBIPL 22N D3 | In distribution | |
| AC LBD4M 25W D2 | In distribution | |
| AC LCD4M 28N D3 | In distribution | |
| AC LCDML 24W D2 | In distribution | |
| AC RCD4M 22N D2 | In distribution | |
| AC LBIPL 25N D3 | In distribution | |
| AC LBD4L 24N D2 | In distribution | |
| AC LBDFL 27N D1 | In distribution | |
| AC RCDMM 26N D2 | In distribution | |
| AC LCDMM 26N D3 | In distribution | |
| AC RBDML 26N D1 | In distribution | |
| AC LCDML 21N D3 | In distribution | |
| AC LCD4M 27N D1 | In distribution | |
| AC RBDMM 26W D1 | In distribution | |
| AC LBD4L 26W D2 | In distribution | |
| AC LCD4M 28N D2 | In distribution | |
| AC RCDMM 23N D2 | In distribution | |
| AC RCDML 22N D3 | In distribution | |
| AC RBDMM 26W D2 | In distribution | |
| AC RCD4L 21N D3 | In distribution | |
| AC RBD4L 21N D2 | In distribution | |
| AC RBDMM 24W D3 | In distribution | |
| AC RCIPL 25N D1 | In distribution | |
| AC LCDFL 24N D3 | In distribution | |
| AC RCIPM 21N D2 | In distribution | |
| AC RBDMM 21N D1 | In distribution | |
| AC RCIPL 28N D3 | In distribution | |
| AC RCIPM 24W D1 | In distribution | |
| AC RCDFL 25W D2 | In distribution | |
| AC LBIPM 28N D2 | In distribution | |
| AC LCDFL 26W D3 | In distribution | |
| AC LBD4L 28N D1 | In distribution | |
| AC RCIPL 23W D2 | In distribution | |
| AC RCDMM 22N D2 | In distribution | |
| AC RBDMM 26N D1 | In distribution | |
| AC LBDMM 24N D1 | In distribution | |
| AC LBDMM 21N D1 | In distribution | |
| AC RBDML 21N D3 | In distribution | |
| AC LBDFL 25N D3 | In distribution | |
| AC RBDML 28N D2 | In distribution | |
| AC LCDFM 26N D2 | In distribution | |
| AC RBIPM 23W D3 | In distribution | |
| AC RBDMM 24N D2 | In distribution | |
| AC RBIPL 26N D2 | In distribution | |
| AC LCDFL 27N D1 | In distribution | |
| AC LBDFL 25N D1 | In distribution | |
| AC RBDFM 22N D2 | In distribution | |
| AC RCDMM 24W D3 | In distribution | |
| AC LBDFM 22N D2 | In distribution | |
| AC LCIPL 26W D1 | In distribution | |
| AC RBIPM 26W D1 | In distribution | |
| AC LCDML 22N D3 | In distribution | |
| AC RCIPM 26N D3 | In distribution | |
| AC LBDFM 28N D2 | In distribution | |
| AC RCD4L 28N D3 | In distribution | |
| AC RCDFM 26W D1 | In distribution | |
| AC LBDFM 28N D1 | In distribution | |
| AC RCDFM 24W D1 | In distribution | |
| AC RBIPL 26N D3 | In distribution | |
| AC RCD4L 25W D3 | In distribution | |
| AC RCDFL 22N D1 | In distribution | |
| AC LCDML 26N D2 | In distribution | |
| AC LCDFL 25N D3 | In distribution | |
| AC LCDML 24N D1 | In distribution | |
| AC LCIPL 25N D3 | In distribution | |
| AC LCDMM 27N D3 | In distribution | |
| AC LBD4M 21N D3 | In distribution | |
| AC RCD4M 25W D2 | In distribution | |
| AC RCDFL 23N D2 | In distribution | |
| AC LCDMM 21N D3 | In distribution | |
| AC LBDML 27N D1 | In distribution | |
| AC LCD4M 21N D2 | In distribution | |
| AC LCIPM 27N D2 | In distribution | |
| AC RCD4M 28N D3 | In distribution | |
| AC LBD4M 23W D2 | In distribution | |
| AC RBD4M 25W D3 | In distribution | |
| AC RCIPM 26W D1 | In distribution | |
| AC LBDFL 23N D3 | In distribution | |
| AC LBDMM 24N D2 | In distribution | |
| AC RCDML 27N D2 | In distribution | |
| AC LCD4M 25W D3 | In distribution | |
| AC RBIPL 23W D1 | In distribution | |
| AC RCDFM 28N D2 | In distribution | |
| AC RBIPL 22N D1 | In distribution | |
| AC RBDFL 21N D3 | In distribution | |
| AC LBDMM 22N D2 | In distribution | |
| AC LBIPM 21N D1 | In distribution | |
| AC RCIPM 25W D1 | In distribution | |
| AC LBDFL 21N D3 | In distribution | |
| AC LCIPM 25N D1 | In distribution | |
| AC LBDML 22N D3 | In distribution | |
| AC LCDFM 23W D1 | In distribution | |
| AC LBDML 26W D3 | In distribution | |
| AC RBD4L 28N D3 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soleus | College Park Industries | 6,180 |
| Onyx | College Park Industries | 3,048 |
| TruStep | College Park Industries | 2,635 |
| Venture | College Park Industries | 1,560 |
| Trulife | Trulife, Inc. | 1,309 |
| Tribute | College Park Industries | 904 |
| Velocity | College Park Industries | 648 |
| Terrain | College Park Industries | 585 |
| Hoizon HD | College Park Industries | 585 |
| Orbit | College Park Industries | 540 |
| Odyssey K3 | College Park Industries | 450 |
| Aviator | College Park Industries | 405 |
Showing 12 of 39. All products under Component, External, Limb, Ankle/Foot
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-05 | Not classified | Mixed-up of materials/components | An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure, which could be | 11 | 2012-07-31 |
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.