Onyx
Onyx Foot, Right, Jet Black, DP 4HPA, 30cm, Narrow, Category 42
14manufacturers in China registered for this device type
3,048catalogue 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 | 2023-11-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OX RJDM 25W D21 | In distribution | |
| OX LBDM 27W D11 | In distribution | |
| OX RBDM 23N D31 | In distribution | |
| OX RCDF 30N D53 | In distribution | |
| OX LTDM 25W D21 | In distribution | |
| OX RTDF 25N D11 | In distribution | |
| OX RCDM 28W D42 | In distribution | |
| OX LTD4 27W D21 | In distribution | |
| OX LCDF 24W D44 | In distribution | |
| OX RTDM 26W D31 | In distribution | |
| OX LBDF 22N D11 | In distribution | |
| OX LCDM 24W D31 | In distribution | |
| OX LTD4 30W D43 | In distribution | |
| OX RJD4 30N D42 | In distribution | |
| OX LCD4 25W D32 | In distribution | |
| OX LCD4 26W D11 | In distribution | |
| OX LJD4 26N D32 | In distribution | |
| OX LBD4 30N D32 | In distribution | |
| OX RTD4 30W D42 | In distribution | |
| OX RCD4 29N D54 | In distribution | |
| OX RTDF 29W D11 | In distribution | |
| OX RBDM 29N D11 | In distribution | |
| OX LJDM 26W D31 | In distribution | |
| OX RJDF 29N D31 | In distribution | |
| OX RBD4 24W D11 | In distribution | |
| OX LBDF 27W D42 | In distribution | |
| OX RCDF 29N D21 | In distribution | |
| OX RTDM 30N D42 | In distribution | |
| OX RJDM 25W D44 | In distribution | |
| OX LJDF 23N D21 | In distribution | |
| OX LTD4 30N D42 | In distribution | |
| OX LJDM 26W D42 | In distribution | |
| OX LCDM 21N D31 | In distribution | |
| OX LTD4 27N D32 | In distribution | |
| OX LJDF 24W D21 | In distribution | |
| OX LJD4 21N D21 | In distribution | |
| OX RJDF 30W D31 | In distribution | |
| OX LBDM 28N D43 | In distribution | |
| OX RBDM 27N D53 | In distribution | |
| OX RCDM 25N D32 | In distribution | |
| OX LJDM 25N D42 | In distribution | |
| OX LTDF 29W D21 | In distribution | |
| OX LBDM 29N D54 | In distribution | |
| OX RCDF 23N D32 | In distribution | |
| OX RTDM 23N D42 | In distribution | |
| OX RBDF 26W D11 | In distribution | |
| OX LTDF 29W D11 | In distribution | |
| OX RTD4 29N D11 | In distribution | |
| OX LCD4 30W D21 | In distribution | |
| OX LTDM 27N D11 | In distribution | |
| OX LCD4 29N D53 | In distribution | |
| OX LJD4 29N D31 | In distribution | |
| OX LBDF 29N D53 | In distribution | |
| OX LTDF 27N D42 | In distribution | |
| OX RJDM 24W D31 | In distribution | |
| OX LCDF 30W D21 | In distribution | |
| OX LJDM 26N D21 | In distribution | |
| OX RCDF 23N D43 | In distribution | |
| OX RTDM 29W D53 | In distribution | |
| OX LTDF 22N D21 | In distribution | |
| OX RCD4 23N D42 | In distribution | |
| OX LJDF 24N D44 | In distribution | |
| OX RJDM 30N D31 | In distribution | |
| OX LCDF 26N D31 | In distribution | |
| OX LCDM 29N D42 | In distribution | |
| OX RJDM 29W D53 | In distribution | |
| OX RCD4 22N D32 | In distribution | |
| OX LJDF 24W D43 | In distribution | |
| OX RBDM 24N D11 | In distribution | |
| OX LJDF 29N D21 | In distribution | |
| OX RCD4 30W D54 | In distribution | |
| OX RCD4 26W D43 | In distribution | |
| OX LJDF 30W D32 | In distribution | |
| OX LBD4 28W D31 | In distribution | |
| OX RJD4 28N D42 | In distribution | |
| OX RTDF 26W D42 | In distribution | |
| OX RBD4 24W D44 | In distribution | |
| OX LBD4 30N D43 | In distribution | |
| OX LCD4 24W D31 | In distribution | |
| OX LBD4 27W D32 | In distribution | |
| OX RTD4 24W D32 | In distribution | |
| OX LJDF 22N D44 | In distribution | |
| OX RTDM 29N D21 | In distribution | |
| OX RCDF 21N D43 | In distribution | |
| OX RTDF 24N D44 | In distribution | |
| OX RTDF 24N D21 | In distribution | |
| OX RJDF 27W D53 | In distribution | |
| OX RBDF 22N D31 | In distribution | |
| OX LTDF 27W D11 | In distribution | |
| OX RTDF 24N D42 | In distribution | |
| OX RCDM 24N D44 | In distribution | |
| OX LCD4 24N D32 | In distribution | |
| OX RBDF 25N D42 | In distribution | |
| OX RBDF 28N D53 | In distribution | |
| OX RCDF 28N D11 | In distribution | |
| OX LBDF 28N D32 | In distribution | |
| OX LCDF 29W D32 | In distribution | |
| OX RJDM 25N D43 | In distribution | |
| OX LJD4 30N D31 | In distribution | |
| OX LTD4 27N D42 | In distribution | |
| OX RTD4 24N D11 | In distribution | |
| OX RTD4 29W D54 | In distribution | |
| OX RBDM 22N D11 | In distribution | |
| OX LBDF 30N D32 | In distribution | |
| OX LCDF 24N D11 | In distribution | |
| OX RCD4 26N D43 | In distribution | |
| OX RBD4 29N D31 | In distribution | |
| OX LCD4 26W D21 | In distribution | |
| OX LBD4 26N D21 | In distribution | |
| OX RTDF 27N D54 | In distribution | |
| OX RBDF 30N D31 | In distribution | |
| OX LTDM 29W D54 | In distribution | |
| OX LTD4 29W D43 | In distribution | |
| OX RCD4 26N D32 | In distribution | |
| OX LBD4 30W D43 | In distribution | |
| OX RCD4 27W D21 | In distribution | |
| OX LTDF 21N D11 | In distribution | |
| OX LBD4 21N D11 | In distribution | |
| OX LJD4 27N D32 | In distribution | |
| OX RCDF 27W D31 | In distribution | |
| OX LCDM 22N D31 | In distribution | |
| OX RTDF 25N D31 | In distribution | |
| OX RJDM 22N D43 | In distribution | |
| OX LTD4 25N D43 | In distribution | |
| OX RCD4 25N D11 | In distribution | |
| OX LBDF 22N D42 | In distribution | |
| OX LBDF 29N D43 | In distribution | |
| OX LTDF 30W D21 | In distribution | |
| OX LJD4 29W D21 | In distribution | |
| OX LJDM 28N D42 | In distribution | |
| OX RJD4 27N D31 | In distribution | |
| OX RTD4 27N D11 | In distribution | |
| OX RJD4 30W D53 | In distribution | |
| OX LJDF 27N D21 | In distribution | |
| OX RBD4 29W D32 | In distribution | |
| OX LCDM 27N D54 | In distribution | |
| OX LTDM 22N D31 | In distribution | |
| OX RBD4 30N D42 | In distribution | |
| OX LCDF 25W D21 | In distribution | |
| OX RJDF 27N D21 | In distribution | |
| OX RJDM 28W D54 | In distribution | |
| OX LTDM 29N D53 | In distribution | |
| OX RBDF 24N D42 | In distribution | |
| OX LTDM 23N D31 | In distribution | |
| OX RTD4 25W D42 | In distribution | |
| OX RTDF 28W D54 | In distribution | |
| OX LJDF 23N D44 | In distribution | |
| OX RTDM 22N D42 | In distribution | |
| OX LCDF 28W D53 | In distribution | |
| OX RTDM 24W D11 | In distribution | |
| OX LJDF 27N D43 | In distribution | |
| OX RBD4 29W D54 | In distribution | |
| OX RBDF 30N D54 | In distribution | |
| OX RJDF 30W D32 | In distribution | |
| OX RTD4 25W D44 | In distribution | |
| OX RBDM 24W D44 | In distribution | |
| OX LTDF 26N D44 | In distribution | |
| OX RTD4 25W D43 | In distribution | |
| OX RCD4 27W D42 | In distribution | |
| OX LJD4 26W D31 | In distribution | |
| OX LCDF 27W D43 | In distribution | |
| OX RJD4 24N D31 | In distribution | |
| OX LCDM 28N D31 | In distribution | |
| OX LTDF 24W D42 | In distribution | |
| OX RJDF 25N D11 | In distribution | |
| OX RBDF 27W D31 | In distribution | |
| OX LCDM 25W D31 | In distribution | |
| OX LCDM 26W D11 | In distribution | |
| OX LTDF 30N D21 | In distribution | |
| OX RCD4 26W D11 | In distribution | |
| OX RBDF 28N D43 | In distribution | |
| OX LTDF 24W D31 | In distribution | |
| OX RJDM 30W D21 | In distribution | |
| OX RCDF 26N D11 | In distribution | |
| OX LJDM 23N D43 | In distribution | |
| OX RTDM 25N D32 | In distribution | |
| OX RCDM 30N D54 | In distribution | |
| OX RJDF 27W D42 | In distribution | |
| OX LJDM 24W D31 | In distribution | |
| OX RJDF 24N D31 | In distribution | |
| OX LBDM 25W D44 | In distribution | |
| OX RJD4 26N D32 | In distribution | |
| OX LBDM 28W D42 | In distribution | |
| OX LCD4 30N D31 | In distribution | |
| OX LCDM 26W D31 | In distribution | |
| OX RBDF 29W D31 | In distribution | |
| OX RCDM 28W D31 | In distribution | |
| OX LJD4 24W D31 | In distribution | |
| OX LTDM 27W D21 | In distribution | |
| OX LJD4 24W D32 | In distribution | |
| OX RTDM 30W D42 | In distribution | |
| OX RTDM 25W D43 | In distribution | |
| OX RCDM 28W D11 | In distribution | |
| OX RTDM 30W D54 | In distribution | |
| OX LJDF 25N D21 | In distribution | |
| OX LBD4 22N D43 | In distribution | |
| OX RJDF 27N D42 | In distribution | |
| OX LTD4 26N D42 | In distribution | |
| OX RTD4 22N D11 | In distribution | |
| OX RBDM 28N D54 | In distribution | |
| OX LJDM 24N D43 | In distribution | |
| OX RJDF 29W D42 | In distribution | |
| OX LTDF 29N D32 | In distribution | |
| OX LJDF 30N D21 | In distribution | |
| OX RJD4 22N D11 | In distribution | |
| OX LJDF 27N D32 | In distribution | |
| OX RJDF 22N D11 | In distribution | |
| OX RBD4 27N D32 | In distribution | |
| OX RBDF 30W D42 | In distribution | |
| OX LTD4 26N D44 | In distribution | |
| OX LJDM 26N D44 | In distribution | |
| OX RCDF 30N D31 | In distribution | |
| OX RJD4 25N D31 | In distribution | |
| OX RBD4 29W D42 | In distribution | |
| OX RBDF 30W D32 | In distribution | |
| OX LBD4 26W D43 | In distribution | |
| OX LCDM 27W D11 | In distribution | |
| OX LJD4 24W D43 | In distribution | |
| OX LCDM 22N D43 | In distribution | |
| OX LCDM 29N D53 | In distribution | |
| OX LJDM 23N D32 | In distribution | |
| OX RJDF 22N D32 | In distribution | |
| OX LTD4 29N D53 | In distribution | |
| OX RJDM 29W D21 | In distribution | |
| OX RJDF 28N D42 | In distribution | |
| OX LBDF 29N D32 | In distribution | |
| OX LCDF 30W D32 | In distribution | |
| OX RBD4 21N D32 | In distribution | |
| OX LJDF 29N D53 | In distribution | |
| OX LBDF 23N D43 | In distribution | |
| OX LBDM 21N D44 | In distribution | |
| OX RCDM 30N D32 | In distribution | |
| OX RTDF 29N D54 | In distribution | |
| OX RTDM 29N D32 | In distribution | |
| OX RBD4 28W D42 | In distribution | |
| OX LJDF 22N D32 | In distribution | |
| OX RTDF 29N D21 | In distribution | |
| OX RCDF 28N D54 | In distribution | |
| OX LJDM 30N D43 | In distribution | |
| OX LTD4 28W D31 | In distribution | |
| OX LTDF 22N D42 | In distribution | |
| OX RTD4 25W D21 | In distribution | |
| OX RCD4 27W D11 | In distribution | |
| OX LCDF 24W D32 | In distribution | |
| OX LTD4 28W D21 | In distribution | |
| OX RTDF 21N D32 | In distribution | |
| OX RCD4 27N D53 | In distribution | |
| OX LBDM 24W D31 | In distribution | |
| OX LCDF 28W D43 | In distribution | |
| OX RCDF 24N D43 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soleus | College Park Industries | 6,180 |
| 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 |
| 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.