TruStep
Trustep Foot, Right, Jet Black, Exo ALX, 29cm, Narrow, Category 7
14manufacturers in China registered for this device type
2,635catalogue 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 | 2023-10-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS RCEN 24W D4 | In distribution | |
| TS RTALX 27W D6 | In distribution | |
| TS RTALX 24N D9 | In distribution | |
| TS LBEN 28W D4 | In distribution | |
| TS LBALX 25N D5 | In distribution | |
| TS LBEN 26W D8 | In distribution | |
| TS RBEN 24W D4 | In distribution | |
| TS RJEN 29W D8 | In distribution | |
| TS RTALX 27N D1 | In distribution | |
| TS RJALX 29N D7 | In distribution | |
| TS RBALX 22N D8 | In distribution | |
| TS LBEN 24N D4 | In distribution | |
| TS RTEN 25W D8 | In distribution | |
| TS LJEN 26W D8 | In distribution | |
| TS RJALX 25W D1 | In distribution | |
| TS LCALX 22N D2 | In distribution | |
| TS RTALX 28W D1 | In distribution | |
| TS LEN 22 D3 | In distribution | |
| TS LTEN 30W D7 | In distribution | |
| TS LJEN 24W D3 | In distribution | |
| TS REN 24 D7 | In distribution | |
| TS RBEN 29N D1 | In distribution | |
| TS RCEN 26N D2 | In distribution | |
| TS RJALX 24W D8 | In distribution | |
| TS RCEN 29N D8 | In distribution | |
| TS RTEN 24N D6 | In distribution | |
| TS REN 22 D7 | In distribution | |
| TS LBEN 24W D2 | In distribution | |
| TS RTALX 27W D4 | In distribution | |
| TS LEN 24 D5 | In distribution | |
| TS RJEN 23N D1 | In distribution | |
| TS RCEN 24N D6 | In distribution | |
| TS LTEN 26N D2 | In distribution | |
| TS RBEN 22N D3 | In distribution | |
| TS LTALX 28N D3 | In distribution | |
| TS ALX 31 D4 | In distribution | |
| TS RJEN 29N D6 | In distribution | |
| TS LJALX 24W D3 | In distribution | |
| TS LALX 22 D9 | In distribution | |
| TS LEN 25 D6 | In distribution | |
| TS LJEN 27W D5 | In distribution | |
| TS LJALX 28W D1 | In distribution | |
| TS LTALX 24W D9 | In distribution | |
| TS RCALX 28N D3 | In distribution | |
| TS LTEN 24W D3 | In distribution | |
| TS LTEN 26W D7 | In distribution | |
| TS LTALX 26W D6 | In distribution | |
| TS RTALX 26W D5 | In distribution | |
| TS LEN 22 D8 | In distribution | |
| TS RBALX 22N D7 | In distribution | |
| TS LTALX 25W D2 | In distribution | |
| TS RJALX 24N D3 | In distribution | |
| TS RTALX 29W D4 | In distribution | |
| TS RJALX 22N D6 | In distribution | |
| TS LCEN 28W D3 | In distribution | |
| TS LEN 29 D4 | In distribution | |
| TS LEN 25 D2 | In distribution | |
| TS RCEN 28W D7 | In distribution | |
| TS LALX 25 D2 | In distribution | |
| TS LCALX 30W D2 | In distribution | |
| TS RTALX 26N D2 | In distribution | |
| TS LCALX 24W D5 | In distribution | |
| TS LTALX 29W D2 | In distribution | |
| TS RTALX 26N D5 | In distribution | |
| TS RTALX 31W D4 | In distribution | |
| TS RCEN 31W D7 | In distribution | |
| TS REN 27 D1 | In distribution | |
| TS RJALX 31W D7 | In distribution | |
| TS RJALX 29N D8 | In distribution | |
| TS RCALX 29N D3 | In distribution | |
| TS LJALX 28N D5 | In distribution | |
| TS LJEN 25W D6 | In distribution | |
| TS LBALX 22N D6 | In distribution | |
| TS LTALX 29W D1 | In distribution | |
| TS RTALX 27W D8 | In distribution | |
| TS LJEN 24N D8 | In distribution | |
| TS REN 24 D1 | In distribution | |
| TS LEN 29 D7 | In distribution | |
| TS LEN 22 D5 | In distribution | |
| TS RTALX 24N D6 | In distribution | |
| TS RBEN 30N D8 | In distribution | |
| TS LALX 25 D3 | In distribution | |
| TS LTEN 27N D6 | In distribution | |
| TS LTALX 27N D4 | In distribution | |
| TS RCEN 24W D7 | In distribution | |
| TS RTEN 30N D2 | In distribution | |
| TS RJALX 29W D5 | In distribution | |
| TS RCEN 22N D7 | In distribution | |
| TS LCEN 27W D6 | In distribution | |
| TS LBEN 28W D8 | In distribution | |
| TS LBALX 30W D3 | In distribution | |
| TS LJALX 28N D6 | In distribution | |
| TS RCALX 22N D9 | In distribution | |
| TS RBEN 24N D8 | In distribution | |
| TS LALX 28 D7 | In distribution | |
| TS RCEN 30N D1 | In distribution | |
| TS LBALX 25W D8 | In distribution | |
| TS RCEN 30W D7 | In distribution | |
| TS LTALX 26N D3 | In distribution | |
| TS RCALX 27W D9 | In distribution | |
| TS RTEN 27N D8 | In distribution | |
| TS RBEN 27N D4 | In distribution | |
| TS RBEN 29W D7 | In distribution | |
| TS LEN 27 D2 | In distribution | |
| TS LJALX 31W D9 | In distribution | |
| TS LEN 28 D5 | In distribution | |
| TS LTALX 26W D4 | In distribution | |
| TS RTALX 24N D8 | In distribution | |
| TS LCEN 27N D8 | In distribution | |
| TS LCEN 27W D7 | In distribution | |
| TS RBALX 27N D8 | In distribution | |
| TS RCALX 28W D6 | In distribution | |
| TS RBEN 30W D8 | In distribution | |
| TS LCALX 27W D8 | In distribution | |
| TS LTALX 25W D5 | In distribution | |
| TS RJALX 27N D1 | In distribution | |
| TS RTALX 28N D8 | In distribution | |
| TS LCEN 27W D8 | In distribution | |
| TS RTEN 28W D3 | In distribution | |
| TS RALX 27 D5 | In distribution | |
| TS RBALX 29W D4 | In distribution | |
| TS RTALX 23N D9 | In distribution | |
| TS RBEN 25W D8 | In distribution | |
| TS RTEN 23N D4 | In distribution | |
| TS LTALX 25N D3 | In distribution | |
| TS RBALX 30W D6 | In distribution | |
| TS LCALX 31W D1 | In distribution | |
| TS RBALX 29W D2 | In distribution | |
| TS RCALX 30W D9 | In distribution | |
| TS LJEN 30N D4 | In distribution | |
| TS LCALX 26N D1 | In distribution | |
| TS RCALX 26N D4 | In distribution | |
| TS RTEN 25W D5 | In distribution | |
| TS LJEN 30N D8 | In distribution | |
| TS LBALX 26W D9 | In distribution | |
| TS RJEN 24W D8 | In distribution | |
| TS RTEN 27W D2 | In distribution | |
| TS LJEN 25N D2 | In distribution | |
| TS LJALX 22N D3 | In distribution | |
| TS LTEN 28W D7 | In distribution | |
| TS LBEN 23N D8 | In distribution | |
| TS RTEN 25W D4 | In distribution | |
| TS RTEN 28W D5 | In distribution | |
| TS REN 22 D4 | In distribution | |
| TS LTALX 30W D6 | In distribution | |
| TS LBEN 28N D5 | In distribution | |
| TS RTEN 22N D6 | In distribution | |
| TS RJEN 25W D8 | In distribution | |
| TS LTALX 23N D9 | In distribution | |
| TS LTEN 26N D1 | In distribution | |
| TS LTEN 23N D7 | In distribution | |
| TS RTEN 28W D6 | In distribution | |
| TS REN 28 D6 | In distribution | |
| TS LJEN 27N D6 | In distribution | |
| TS LJALX 25N D8 | In distribution | |
| TS LJALX 29W D1 | In distribution | |
| TS LALX 26 D2 | In distribution | |
| TS LALX 29 D8 | In distribution | |
| TS LTALX 25N D9 | In distribution | |
| TS LTALX 22N D8 | In distribution | |
| TS RBALX 24N D3 | In distribution | |
| TS RTEN 27N D1 | In distribution | |
| TS LCALX 29N D5 | In distribution | |
| TS LTALX 31W D7 | In distribution | |
| TS REN 27 D6 | In distribution | |
| TS LCALX 24W D1 | In distribution | |
| TS LBALX 24W D4 | In distribution | |
| TS LCALX 26N D2 | In distribution | |
| TS RJEN 29W D7 | In distribution | |
| TS LCALX 23N D6 | In distribution | |
| TS RBALX 27N D6 | In distribution | |
| TS LTALX 25W D6 | In distribution | |
| TS RTEN 27W D1 | In distribution | |
| TS REN 29 D4 | In distribution | |
| TS RBEN 30W D7 | In distribution | |
| TS RJEN 25N D7 | In distribution | |
| TS RBALX 29N D7 | In distribution | |
| TS RCALX 31W D1 | In distribution | |
| TS LTEN 22N D3 | In distribution | |
| TS LJALX 26N D6 | In distribution | |
| TS LJEN 28W D1 | In distribution | |
| TS LBALX 25W D3 | In distribution | |
| TS RCALX 24W D5 | In distribution | |
| TS LBEN 27N D5 | In distribution | |
| TS RALX 30 D4 | In distribution | |
| TS LTEN 24N D1 | In distribution | |
| TS RCEN 23N D4 | In distribution | |
| TS LTEN 30N D6 | In distribution | |
| TS LALX 27 D9 | In distribution | |
| TS RBEN 26N D4 | In distribution | |
| TS RBEN 29N D4 | In distribution | |
| TS LBALX 22N D5 | In distribution | |
| TS RJEN 26N D6 | In distribution | |
| TS LEN 26 D7 | In distribution | |
| TS RCEN 30W D3 | In distribution | |
| TS RJEN 28N D4 | In distribution | |
| TS RCALX 30N D3 | In distribution | |
| TS RBALX 27W D1 | In distribution | |
| TS LBALX 24W D6 | In distribution | |
| TS RBALX 27N D9 | In distribution | |
| TS RCALX 23N D8 | In distribution | |
| TS RJALX 25N D6 | In distribution | |
| TS RBEN 31W D1 | In distribution | |
| TS RCEN 28N D2 | In distribution | |
| TS RCALX 30N D7 | In distribution | |
| TS RJALX 26W D6 | In distribution | |
| TS RTALX 22N D5 | In distribution | |
| TS RTALX 28N D4 | In distribution | |
| TS RJALX 28W D3 | In distribution | |
| TS RJALX 29N D1 | In distribution | |
| TS LTEN 27W D7 | In distribution | |
| TS LBEN 25N D2 | In distribution | |
| TS RBEN 26N D7 | In distribution | |
| TS RTALX 26W D4 | In distribution | |
| TS LJEN 27N D4 | In distribution | |
| TS RBALX 25N D4 | In distribution | |
| TS RCALX 26W D2 | In distribution | |
| TS LJALX 25W D4 | In distribution | |
| TS RTALX 24W D6 | In distribution | |
| TS RTALX 29W D5 | In distribution | |
| TS LBEN 25N D3 | In distribution | |
| TS RCEN 24N D3 | In distribution | |
| TS REN 29 D7 | In distribution | |
| TS LJALX 28W D3 | In distribution | |
| TS RJALX 24N D1 | In distribution | |
| TS LTEN 30N D8 | In distribution | |
| TS RBALX 30W D4 | In distribution | |
| TS RCALX 28N D5 | In distribution | |
| TS LCEN 24N D7 | In distribution | |
| TS RCEN 29N D7 | In distribution | |
| TS RTEN 29N D2 | In distribution | |
| TS LCALX 25W D7 | In distribution | |
| TS REN 27 D3 | In distribution | |
| TS LBALX 23N D1 | In distribution | |
| TS LTALX 29W D5 | In distribution | |
| TS LJALX 26N D3 | In distribution | |
| TS RCEN 26N D7 | In distribution | |
| TS LCEN 29N D7 | In distribution | |
| TS LEN 30 D8 | In distribution | |
| TS LCEN 25W D7 | In distribution | |
| TS LCALX 23N D4 | In distribution | |
| TS REN 26 D4 | In distribution | |
| TS LTALX 29N D7 | In distribution | |
| TS LJALX 24N D6 | In distribution | |
| TS RTALX 22N D8 | In distribution | |
| TS LCEN 23N D2 | In distribution | |
| TS LJEN 22N D2 | In distribution | |
| TS RBEN 30W D4 | In distribution | |
| TS RJEN 26W D2 | In distribution | |
| TS RTEN 31W D5 | 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 |
| Venture | College Park Industries | 1,560 |
| Trulife | Trulife, Inc. | 1,309 |
| Accent | College Park Industries | 1,152 |
| 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.