Tribute
Tribute Foot, Right, Caucasian, Endo IP, Sandal Toe, 24cm, Category 2
14manufacturers in China registered for this device type
904catalogue numbers in this listing
1recall
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 | 2023-10-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TB RTENS 23 D4 | In distribution | |
| TB ENS 21 D2 | In distribution | |
| TB REN 23 D4 | In distribution | |
| TB RBEN 27N D4 | In distribution | |
| TB LCEN 29W D2 | In distribution | |
| TB LCEN 28W D3 | In distribution | |
| TB RTEN 28W D3 | In distribution | |
| TB LBEN 30W D4 | In distribution | |
| TB RCEN 24N D4 | In distribution | |
| TB RJEN 28W D1 | In distribution | |
| TB LEN 28 D3 | In distribution | |
| TB RCEN 26W D1 | In distribution | |
| TB RTEN 28W D4 | In distribution | |
| TB ENS 25 D4 | In distribution | |
| TB LEN 29 D4 | In distribution | |
| TB RBENS 21 D2 | In distribution | |
| TB RBEN 21N D4 | In distribution | |
| TB RBEN 28W D1 | In distribution | |
| TB RCEN 26N D3 | In distribution | |
| TB LJEN 21N D3 | In distribution | |
| TB LTEN 25N D4 | In distribution | |
| TB LBEN 25W D3 | In distribution | |
| TB REN 22 D1 | In distribution | |
| TB LTENS 23 D4 | In distribution | |
| TB LCEN 26N D2 | In distribution | |
| TB LTEN 27W D4 | In distribution | |
| TB LTENS 30 D3 | In distribution | |
| TB RCEN 30W D3 | In distribution | |
| TB LJEN 25N D2 | In distribution | |
| TB RTEN 28W D2 | In distribution | |
| TB RTENS 26 D4 | In distribution | |
| TB LCEN 29N D2 | In distribution | |
| TB RJEN 25W D4 | In distribution | |
| TB LEN 22 D4 | In distribution | |
| TB LBEN 27W D4 | In distribution | |
| TB RBENS 24 D1 | In distribution | |
| TB LCEN 26W D2 | In distribution | |
| TB LBENS 26 D1 | In distribution | |
| TB RBEN 24W D2 | In distribution | |
| TB LBEN 26W D4 | In distribution | |
| TB RJEN 23N D3 | In distribution | |
| TB LCENS 22 D3 | In distribution | |
| TB RJEN 24N D1 | In distribution | |
| TB LTEN 23N D1 | In distribution | |
| TB ENS 29 D3 | In distribution | |
| TB RJEN 24N D2 | In distribution | |
| TB LCENS 24 D4 | In distribution | |
| TB LTENS 27 D1 | In distribution | |
| TB LCENS 26 D3 | In distribution | |
| TB RJEN 26W D1 | In distribution | |
| TB RCEN 24W D3 | In distribution | |
| TB RJEN 27N D4 | In distribution | |
| TB REN 25 D2 | In distribution | |
| TB LBEN 29W D3 | In distribution | |
| TB RTEN 26N D3 | In distribution | |
| TB RCENS 24 D2 | In distribution | |
| TB LCEN 29W D1 | In distribution | |
| TB LTEN 25N D1 | In distribution | |
| TB RTEN 24N D4 | In distribution | |
| TB RJEN 21N D1 | In distribution | |
| TB LTEN 25W D4 | In distribution | |
| TB RBEN 30N D4 | In distribution | |
| TB LCENS 25 D3 | In distribution | |
| TB RBENS 27 D4 | In distribution | |
| TB ENS 27 D4 | In distribution | |
| TB RCENS 24 D4 | In distribution | |
| TB LCEN 27W D1 | In distribution | |
| TB LJEN 30N D2 | In distribution | |
| TB RCEN 26W D4 | In distribution | |
| TB RTEN 29W D3 | In distribution | |
| TB LCENS 30 D4 | In distribution | |
| TB LBENS 25 D2 | In distribution | |
| TB REN 22 D4 | In distribution | |
| TB LJEN 26N D4 | In distribution | |
| TB LTENS 29 D2 | In distribution | |
| TB LBENS 26 D4 | In distribution | |
| TB RBENS 21 D4 | In distribution | |
| TB REN 26 D2 | In distribution | |
| TB ENS 22 D3 | In distribution | |
| TB RTEN 30N D2 | In distribution | |
| TB LBEN 26N D4 | In distribution | |
| TB LEN 27 D1 | In distribution | |
| TB ENS 29 D2 | In distribution | |
| TB RBEN 27N D3 | In distribution | |
| TB LBEN 22N D1 | In distribution | |
| TB LTEN 27W D1 | In distribution | |
| TB RCEN 28W D1 | In distribution | |
| TB LTEN 27N D4 | In distribution | |
| TB LJEN 28N D3 | In distribution | |
| TB RBEN 24N D2 | In distribution | |
| TB RJEN 27W D4 | In distribution | |
| TB LJEN 28N D4 | In distribution | |
| TB LCENS 30 D3 | In distribution | |
| TB LBEN 28W D1 | In distribution | |
| TB RBEN 21N D1 | In distribution | |
| TB LJEN 27N D4 | In distribution | |
| TB LTEN 30N D1 | In distribution | |
| TB LBEN 28N D1 | In distribution | |
| TB LEN 22 D1 | In distribution | |
| TB LTEN 22N D3 | In distribution | |
| TB RBEN 25W D4 | In distribution | |
| TB RTEN 24W D1 | In distribution | |
| TB LBENS 24 D4 | In distribution | |
| TB RCEN 22N D4 | In distribution | |
| TB LCEN 23N D2 | In distribution | |
| TB LTEN 28W D4 | In distribution | |
| TB LTENS 22 D2 | In distribution | |
| TB REN 26 D4 | In distribution | |
| TB LTENS 26 D2 | In distribution | |
| TB RBENS 21 D3 | In distribution | |
| TB RCEN 25W D2 | In distribution | |
| TB LJEN 28W D2 | In distribution | |
| TB LTENS 28 D2 | In distribution | |
| TB LCEN 27W D4 | In distribution | |
| TB RCEN 26N D1 | In distribution | |
| TB LEN 24 D4 | In distribution | |
| TB LBENS 22 D3 | In distribution | |
| TB LCEN 27N D1 | In distribution | |
| TB LCEN 26N D3 | In distribution | |
| TB LJEN 22N D1 | In distribution | |
| TB RTEN 24W D3 | In distribution | |
| TB RJEN 26N D3 | In distribution | |
| TB LJEN 22N D4 | In distribution | |
| TB RTEN 25W D3 | In distribution | |
| TB LBEN 30N D4 | In distribution | |
| TB RBEN 26W D4 | In distribution | |
| TB RTEN 23N D2 | In distribution | |
| TB RTENS 29 D3 | In distribution | |
| TB LBEN 24N D1 | In distribution | |
| TB LTEN 25W D3 | In distribution | |
| TB LBENS 21 D3 | In distribution | |
| TB LJEN 27W D2 | In distribution | |
| TB LEN 24 D3 | In distribution | |
| TB RTEN 26N D4 | In distribution | |
| TB LCEN 24N D1 | In distribution | |
| TB LJEN 26W D2 | In distribution | |
| TB LTENS 23 D3 | In distribution | |
| TB LCENS 28 D1 | In distribution | |
| TB LEN 22 D3 | In distribution | |
| TB LCEN 27N D3 | In distribution | |
| TB RTEN 29N D1 | In distribution | |
| TB RTENS 22 D3 | In distribution | |
| TB LJEN 29N D2 | In distribution | |
| TB REN 23 D3 | In distribution | |
| TB RBEN 30W D3 | In distribution | |
| TB LCEN 28W D4 | In distribution | |
| TB RTEN 28N D1 | In distribution | |
| TB LCENS 27 D2 | In distribution | |
| TB RCEN 29W D4 | In distribution | |
| TB LTEN 30W D1 | In distribution | |
| TB RBEN 26N D4 | In distribution | |
| TB LBEN 30W D2 | In distribution | |
| TB RCEN 26N D2 | In distribution | |
| TB LCEN 25N D3 | In distribution | |
| TB LCEN 23N D3 | In distribution | |
| TB LCEN 30N D2 | In distribution | |
| TB RCENS 30 D1 | In distribution | |
| TB LTEN 21N D2 | In distribution | |
| TB RCEN 27W D4 | In distribution | |
| TB LBEN 27N D1 | In distribution | |
| TB RJEN 25W D1 | In distribution | |
| TB LTEN 29W D4 | In distribution | |
| TB RCEN 24N D1 | In distribution | |
| TB LJEN 21N D1 | In distribution | |
| TB RJEN 29N D1 | In distribution | |
| TB LBEN 26N D1 | In distribution | |
| TB LTENS 23 D2 | In distribution | |
| TB LTENS 23 D1 | In distribution | |
| TB RTEN 30W D1 | In distribution | |
| TB RCEN 30W D1 | In distribution | |
| TB RCEN 27W D3 | In distribution | |
| TB LTENS 27 D2 | In distribution | |
| TB REN 22 D3 | In distribution | |
| TB RCENS 23 D2 | In distribution | |
| TB LJEN 28N D2 | In distribution | |
| TB LEN 29 D3 | In distribution | |
| TB RJEN 28W D3 | In distribution | |
| TB ENS 27 D1 | In distribution | |
| TB LCENS 25 D1 | In distribution | |
| TB LCENS 24 D3 | In distribution | |
| TB LJEN 27W D4 | In distribution | |
| TB RBEN 29W D1 | In distribution | |
| TB LJEN 26W D3 | In distribution | |
| TB RTEN 29W D4 | In distribution | |
| TB RBEN 24W D1 | In distribution | |
| TB LBEN 30N D1 | In distribution | |
| TB RCENS 26 D3 | In distribution | |
| TB LJEN 25W D1 | In distribution | |
| TB RTEN 26N D2 | In distribution | |
| TB RTENS 28 D1 | In distribution | |
| TB LJEN 26W D4 | In distribution | |
| TB REN 27 D3 | In distribution | |
| TB LTEN 27W D3 | In distribution | |
| TB RCEN 27N D4 | In distribution | |
| TB REN 25 D3 | In distribution | |
| TB RBEN 29N D2 | In distribution | |
| TB RBEN 24W D4 | In distribution | |
| TB LBENS 29 D1 | In distribution | |
| TB LTEN 29N D3 | In distribution | |
| TB LCEN 21N D1 | In distribution | |
| TB LCENS 26 D1 | In distribution | |
| TB RBEN 26W D1 | In distribution | |
| TB RTEN 22N D3 | In distribution | |
| TB RJEN 29N D2 | In distribution | |
| TB LTENS 24 D4 | In distribution | |
| TB LTEN 24W D3 | In distribution | |
| TB RCEN 30N D1 | In distribution | |
| TB RBENS 26 D3 | In distribution | |
| TB LBEN 30W D1 | In distribution | |
| TB LCEN 22N D3 | In distribution | |
| TB ENS 23 D1 | In distribution | |
| TB LTEN 27W D2 | In distribution | |
| TB LJEN 29W D4 | In distribution | |
| TB RJEN 29N D3 | In distribution | |
| TB LBENS 22 D4 | In distribution | |
| TB LTENS 25 D1 | In distribution | |
| TB RCEN 28N D4 | In distribution | |
| TB ENS 24 D2 | In distribution | |
| TB LBENS 30 D2 | In distribution | |
| TB LBEN 29N D3 | In distribution | |
| TB RCENS 28 D1 | In distribution | |
| TB LTEN 24N D1 | In distribution | |
| TB RBEN 29W D2 | In distribution | |
| TB LCEN 28N D2 | In distribution | |
| TB LCENS 30 D2 | In distribution | |
| TB LTEN 24N D2 | In distribution | |
| TB RBEN 26W D3 | In distribution | |
| TB RBENS 21 D1 | In distribution | |
| TB LBEN 25N D3 | In distribution | |
| TB LJEN 26N D3 | In distribution | |
| TB REN 26 D1 | In distribution | |
| TB LCEN 23N D1 | In distribution | |
| TB RTENS 22 D1 | In distribution | |
| TB RBEN 22N D2 | In distribution | |
| TB RBENS 29 D2 | In distribution | |
| TB RTEN 26W D3 | In distribution | |
| TB REN 24 D2 | In distribution | |
| TB RBEN 25N D1 | In distribution | |
| TB LCEN 30W D3 | In distribution | |
| TB LBENS 29 D4 | In distribution | |
| TB RBENS 26 D1 | In distribution | |
| TB RTENS 21 D4 | In distribution | |
| TB LCENS 29 D3 | In distribution | |
| TB LBEN 24W D1 | In distribution | |
| TB LBENS 30 D1 | In distribution | |
| TB RTEN 22N D1 | In distribution | |
| TB RBENS 28 D4 | In distribution | |
| TB LTEN 28N D3 | In distribution | |
| TB LBENS 24 D2 | In distribution | |
| TB RJEN 24N 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 |
| Accent | College Park Industries | 1,152 |
| 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.