Odyssey K3
Odyssey K3 Foot, Right, Jet Black, Endo IP, 30cm, Category 3
14manufacturers in China registered for this device type
450catalogue 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 | 2023-09-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ODK3 RTEN 30 D1 | In distribution | |
| ODK3 LCEN 25 D1 | In distribution | |
| ODK3 LBEN 26 D2 | In distribution | |
| ODK3 EN 21 D4 | In distribution | |
| ODK3 LJEN 28 D4 | In distribution | |
| ODK3 RBEN 26 D3 | In distribution | |
| ODK3 LCEN 24 D2 | In distribution | |
| ODK3 LCEN 23 D2 | In distribution | |
| ODK3 LTEN 21 D1 | In distribution | |
| ODK3 LCEN 24 D1 | In distribution | |
| ODK3 LBEN 25 D2 | In distribution | |
| ODK3 LCEN 28 D2 | In distribution | |
| ODK3 LBEN 27 D4 | In distribution | |
| ODK3 EN 30 D1 | In distribution | |
| ODK3 RTEN 24 D3 | In distribution | |
| ODK3 RJEN 30 D3 | In distribution | |
| ODK3 LTEN 29 D4 | In distribution | |
| ODK3 LJEN 30 D1 | In distribution | |
| ODK3 LTEN 28 D3 | In distribution | |
| ODK3 LTEN 30 D4 | In distribution | |
| ODK3 LCEN 25 D3 | In distribution | |
| ODK3 RTEN 27 D4 | In distribution | |
| ODK3 RJEN 23 D1 | In distribution | |
| ODK3 RTEN 30 D3 | In distribution | |
| ODK3 LCEN 21 D1 | In distribution | |
| ODK3 RTEN 26 D4 | In distribution | |
| ODK3 LBEN 28 D2 | In distribution | |
| ODK3 LTEN 30 D3 | In distribution | |
| ODK3 LJEN 26 D5 | In distribution | |
| ODK3 LJEN 28 D2 | In distribution | |
| ODK3 LBEN 22 D1 | In distribution | |
| ODK3 RTEN 23 D2 | In distribution | |
| ODK3 LTEN 29 D1 | In distribution | |
| ODK3 LJEN 25 D5 | In distribution | |
| ODK3 RJEN 24 D5 | In distribution | |
| ODK3 LTEN 22 D4 | In distribution | |
| ODK3 RJEN 23 D3 | In distribution | |
| ODK3 EN 23 D5 | In distribution | |
| ODK3 RJEN 29 D3 | In distribution | |
| ODK3 RJEN 27 D5 | In distribution | |
| ODK3 LJEN 29 D5 | In distribution | |
| ODK3 RJEN 29 D2 | In distribution | |
| ODK3 LJEN 23 D1 | In distribution | |
| ODK3 EN 23 D3 | In distribution | |
| ODK3 LTEN 30 D2 | In distribution | |
| ODK3 LBEN 26 D5 | In distribution | |
| ODK3 EN 28 D2 | In distribution | |
| ODK3 EN 29 D2 | In distribution | |
| ODK3 RCEN 28 D1 | In distribution | |
| ODK3 RTEN 27 D1 | In distribution | |
| ODK3 RJEN 25 D2 | In distribution | |
| ODK3 EN 23 D1 | In distribution | |
| ODK3 LCEN 23 D1 | In distribution | |
| ODK3 RTEN 26 D1 | In distribution | |
| ODK3 LTEN 25 D1 | In distribution | |
| ODK3 RTEN 29 D2 | In distribution | |
| ODK3 LTEN 21 D4 | In distribution | |
| ODK3 RBEN 28 D1 | In distribution | |
| ODK3 RCEN 30 D2 | In distribution | |
| ODK3 LJEN 29 D3 | In distribution | |
| ODK3 LCEN 21 D2 | In distribution | |
| ODK3 LJEN 21 D2 | In distribution | |
| ODK3 RTEN 27 D5 | In distribution | |
| ODK3 LCEN 25 D2 | In distribution | |
| ODK3 LCEN 30 D1 | In distribution | |
| ODK3 LJEN 25 D4 | In distribution | |
| ODK3 LCEN 22 D1 | In distribution | |
| ODK3 RTEN 21 D4 | In distribution | |
| ODK3 LCEN 28 D3 | In distribution | |
| ODK3 EN 24 D1 | In distribution | |
| ODK3 LCEN 28 D4 | In distribution | |
| ODK3 LBEN 30 D3 | In distribution | |
| ODK3 LBEN 30 D2 | In distribution | |
| ODK3 RJEN 22 D4 | In distribution | |
| ODK3 LCEN 29 D3 | In distribution | |
| ODK3 RTEN 25 D1 | In distribution | |
| ODK3 RBEN 22 D5 | In distribution | |
| ODK3 RTEN 28 D3 | In distribution | |
| ODK3 EN 24 D3 | In distribution | |
| ODK3 LJEN 23 D3 | In distribution | |
| ODK3 LBEN 30 D4 | In distribution | |
| ODK3 RBEN 26 D2 | In distribution | |
| ODK3 EN 22 D3 | In distribution | |
| ODK3 EN 23 D4 | In distribution | |
| ODK3 LTEN 26 D1 | In distribution | |
| ODK3 LJEN 22 D2 | In distribution | |
| ODK3 LBEN 22 D5 | In distribution | |
| ODK3 RTEN 22 D4 | In distribution | |
| ODK3 LTEN 24 D4 | In distribution | |
| ODK3 RCEN 28 D5 | In distribution | |
| ODK3 LCEN 27 D1 | In distribution | |
| ODK3 RCEN 29 D1 | In distribution | |
| ODK3 RJEN 24 D1 | In distribution | |
| ODK3 LCEN 22 D5 | In distribution | |
| ODK3 LBEN 24 D2 | In distribution | |
| ODK3 RTEN 28 D2 | In distribution | |
| ODK3 RTEN 21 D5 | In distribution | |
| ODK3 RCEN 28 D2 | In distribution | |
| ODK3 LCEN 30 D5 | In distribution | |
| ODK3 RBEN 27 D4 | In distribution | |
| ODK3 LTEN 26 D3 | In distribution | |
| ODK3 RTEN 23 D1 | In distribution | |
| ODK3 RTEN 23 D5 | In distribution | |
| ODK3 RBEN 28 D3 | In distribution | |
| ODK3 LJEN 28 D5 | In distribution | |
| ODK3 LBEN 25 D5 | In distribution | |
| ODK3 LJEN 27 D3 | In distribution | |
| ODK3 LTEN 29 D3 | In distribution | |
| ODK3 LTEN 21 D3 | In distribution | |
| ODK3 EN 28 D1 | In distribution | |
| ODK3 RJEN 23 D2 | In distribution | |
| ODK3 LBEN 21 D3 | In distribution | |
| ODK3 LTEN 22 D5 | In distribution | |
| ODK3 LCEN 24 D4 | In distribution | |
| ODK3 LCEN 26 D2 | In distribution | |
| ODK3 RTEN 30 D5 | In distribution | |
| ODK3 RBEN 24 D5 | In distribution | |
| ODK3 RBEN 21 D2 | In distribution | |
| ODK3 LJEN 28 D3 | In distribution | |
| ODK3 LJEN 21 D3 | In distribution | |
| ODK3 LBEN 28 D4 | In distribution | |
| ODK3 RCEN 25 D2 | In distribution | |
| ODK3 RCEN 21 D1 | In distribution | |
| ODK3 RTEN 26 D3 | In distribution | |
| ODK3 RJEN 27 D4 | In distribution | |
| ODK3 EN 25 D3 | In distribution | |
| ODK3 EN 25 D5 | In distribution | |
| ODK3 RCEN 27 D4 | In distribution | |
| ODK3 EN 27 D2 | In distribution | |
| ODK3 RBEN 28 D4 | In distribution | |
| ODK3 RTEN 21 D1 | In distribution | |
| ODK3 RBEN 28 D5 | In distribution | |
| ODK3 EN 30 D4 | In distribution | |
| ODK3 RCEN 28 D4 | In distribution | |
| ODK3 RJEN 29 D4 | In distribution | |
| ODK3 LJEN 22 D3 | In distribution | |
| ODK3 LJEN 26 D2 | In distribution | |
| ODK3 RTEN 29 D3 | In distribution | |
| ODK3 RBEN 29 D5 | In distribution | |
| ODK3 RBEN 21 D4 | In distribution | |
| ODK3 RJEN 24 D2 | In distribution | |
| ODK3 RJEN 25 D3 | In distribution | |
| ODK3 RJEN 30 D4 | In distribution | |
| ODK3 RJEN 29 D5 | In distribution | |
| ODK3 LBEN 26 D4 | In distribution | |
| ODK3 RBEN 29 D1 | In distribution | |
| ODK3 RBEN 21 D5 | In distribution | |
| ODK3 LJEN 29 D4 | In distribution | |
| ODK3 LBEN 27 D2 | In distribution | |
| ODK3 EN 28 D4 | In distribution | |
| ODK3 RJEN 28 D4 | In distribution | |
| ODK3 RJEN 26 D3 | In distribution | |
| ODK3 LJEN 25 D3 | In distribution | |
| ODK3 RCEN 26 D1 | In distribution | |
| ODK3 LBEN 24 D1 | In distribution | |
| ODK3 RBEN 26 D5 | In distribution | |
| ODK3 RTEN 24 D2 | In distribution | |
| ODK3 LBEN 27 D5 | In distribution | |
| ODK3 RBEN 27 D1 | In distribution | |
| ODK3 RBEN 29 D4 | In distribution | |
| ODK3 LCEN 23 D4 | In distribution | |
| ODK3 RBEN 29 D2 | In distribution | |
| ODK3 RTEN 30 D4 | In distribution | |
| ODK3 RTEN 28 D5 | In distribution | |
| ODK3 RCEN 30 D4 | In distribution | |
| ODK3 LTEN 23 D3 | In distribution | |
| ODK3 LTEN 27 D2 | In distribution | |
| ODK3 LBEN 28 D5 | In distribution | |
| ODK3 RBEN 24 D3 | In distribution | |
| ODK3 RJEN 26 D2 | In distribution | |
| ODK3 RJEN 27 D3 | In distribution | |
| ODK3 LTEN 24 D2 | In distribution | |
| ODK3 RBEN 25 D5 | In distribution | |
| ODK3 RBEN 25 D2 | In distribution | |
| ODK3 LBEN 30 D5 | In distribution | |
| ODK3 RTEN 25 D3 | In distribution | |
| ODK3 LTEN 21 D5 | In distribution | |
| ODK3 LTEN 24 D5 | In distribution | |
| ODK3 LJEN 30 D3 | In distribution | |
| ODK3 RBEN 28 D2 | In distribution | |
| ODK3 LTEN 27 D1 | In distribution | |
| ODK3 LJEN 30 D2 | In distribution | |
| ODK3 RTEN 24 D4 | In distribution | |
| ODK3 LCEN 26 D5 | In distribution | |
| ODK3 RBEN 21 D3 | In distribution | |
| ODK3 LTEN 29 D5 | In distribution | |
| ODK3 LCEN 27 D2 | In distribution | |
| ODK3 LBEN 28 D3 | In distribution | |
| ODK3 RBEN 24 D1 | In distribution | |
| ODK3 RJEN 30 D5 | In distribution | |
| ODK3 LJEN 21 D5 | In distribution | |
| ODK3 LJEN 24 D1 | In distribution | |
| ODK3 LTEN 25 D3 | In distribution | |
| ODK3 RBEN 29 D3 | In distribution | |
| ODK3 LBEN 23 D1 | In distribution | |
| ODK3 LTEN 28 D4 | In distribution | |
| ODK3 RTEN 27 D2 | In distribution | |
| ODK3 RCEN 26 D5 | In distribution | |
| ODK3 LTEN 28 D5 | In distribution | |
| ODK3 RJEN 22 D5 | In distribution | |
| ODK3 RCEN 21 D2 | In distribution | |
| ODK3 RCEN 23 D4 | In distribution | |
| ODK3 RTEN 22 D2 | In distribution | |
| ODK3 RCEN 24 D2 | In distribution | |
| ODK3 LCEN 29 D1 | In distribution | |
| ODK3 LJEN 23 D2 | In distribution | |
| ODK3 LJEN 30 D4 | In distribution | |
| ODK3 LCEN 22 D2 | In distribution | |
| ODK3 LBEN 22 D4 | In distribution | |
| ODK3 RBEN 27 D2 | In distribution | |
| ODK3 RCEN 27 D3 | In distribution | |
| ODK3 LTEN 23 D5 | In distribution | |
| ODK3 LJEN 27 D4 | In distribution | |
| ODK3 LTEN 25 D4 | In distribution | |
| ODK3 RCEN 23 D3 | In distribution | |
| ODK3 LBEN 23 D2 | In distribution | |
| ODK3 RCEN 27 D1 | In distribution | |
| ODK3 RCEN 29 D4 | In distribution | |
| ODK3 LTEN 26 D4 | In distribution | |
| ODK3 RJEN 25 D5 | In distribution | |
| ODK3 LCEN 26 D4 | In distribution | |
| ODK3 RCEN 30 D1 | In distribution | |
| ODK3 LCEN 24 D3 | In distribution | |
| ODK3 RBEN 27 D5 | In distribution | |
| ODK3 LBEN 22 D3 | In distribution | |
| ODK3 LTEN 27 D5 | In distribution | |
| ODK3 RBEN 23 D3 | In distribution | |
| ODK3 RTEN 25 D4 | In distribution | |
| ODK3 LCEN 27 D5 | In distribution | |
| ODK3 LBEN 23 D5 | In distribution | |
| ODK3 LJEN 25 D1 | In distribution | |
| ODK3 LCEN 23 D5 | In distribution | |
| ODK3 LJEN 23 D5 | In distribution | |
| ODK3 EN 21 D2 | In distribution | |
| ODK3 LJEN 27 D2 | In distribution | |
| ODK3 RTEN 24 D5 | In distribution | |
| ODK3 RBEN 25 D4 | In distribution | |
| ODK3 LJEN 23 D4 | In distribution | |
| ODK3 LCEN 21 D5 | In distribution | |
| ODK3 LJEN 21 D4 | In distribution | |
| ODK3 RCEN 26 D4 | In distribution | |
| ODK3 LBEN 24 D5 | In distribution | |
| ODK3 LCEN 21 D3 | In distribution | |
| ODK3 EN 28 D5 | In distribution | |
| ODK3 LTEN 22 D1 | In distribution | |
| ODK3 RTEN 22 D1 | In distribution | |
| ODK3 LJEN 24 D3 | In distribution | |
| ODK3 RJEN 21 D5 | In distribution | |
| ODK3 RJEN 24 D4 | In distribution | |
| ODK3 EN 22 D4 | 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 |
| 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 |
| 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.