Soleus
Soleus Foot, Right, Caucasian, Midnight Black Housing, 21cm, Narrow, Category 34
14manufacturers in China registered for this device type
6,180catalogue 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 | 2023-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SO LBG 24W D11 | In distribution | |
| SO LS 28 D55 | In distribution | |
| SO LCS 30N D55 | In distribution | |
| SO RBG 28W D53 | In distribution | |
| SO RJT 25N D12 | In distribution | |
| SO RTS 26W D76 | In distribution | |
| SO LJT 27N D11 | In distribution | |
| SO RBM 21N D34 | In distribution | |
| SO RJP 25W D32 | In distribution | |
| SO RS 27 D32 | In distribution | |
| SO RCP 28W D34 | In distribution | |
| SO RJG 26W D54 | In distribution | |
| SO RJG 22N D33 | In distribution | |
| SO LCS 26N D55 | In distribution | |
| SO LTG 21N D34 | In distribution | |
| SO RTG 26W D76 | In distribution | |
| SO RCS 26W D75 | In distribution | |
| SO RJS 21N D12 | In distribution | |
| SO LJT 23N D34 | In distribution | |
| SO LTS 22N D34 | In distribution | |
| SO RBG 30W D55 | In distribution | |
| SO RBM 29N D11 | In distribution | |
| SO LBS 27N D53 | In distribution | |
| SO RS 25 D75 | In distribution | |
| SO LTP 27N D12 | In distribution | |
| SO RCT 26W D34 | In distribution | |
| SO RCM 30W D55 | In distribution | |
| SO RTS 22N D33 | In distribution | |
| SO LBP 30W D55 | In distribution | |
| SO LJG 26N D32 | In distribution | |
| SO RBT 29W D11 | In distribution | |
| SO LBP 23N D11 | In distribution | |
| SO LCG 21N D11 | In distribution | |
| SO RBM 25W D75 | In distribution | |
| SO LJG 30N D11 | In distribution | |
| SO RJG 25N D56 | In distribution | |
| SO LJM 27N D55 | In distribution | |
| SO RBG 24W D33 | In distribution | |
| SO RBG 30N D12 | In distribution | |
| SO RBS 30W D54 | In distribution | |
| SO RJT 26N D33 | In distribution | |
| SO RT 22 D12 | In distribution | |
| SO LJS 30W D54 | In distribution | |
| SO RBS 26N D12 | In distribution | |
| SO LBS 21N D34 | In distribution | |
| SO LBS 28N D54 | In distribution | |
| SO LCT 23N D32 | In distribution | |
| SO LCT 29N D32 | In distribution | |
| SO RCS 28N D11 | In distribution | |
| SO LJM 27N D34 | In distribution | |
| SO RTG 25W D33 | In distribution | |
| SO LCS 26W D32 | In distribution | |
| SO RBM 22N D34 | In distribution | |
| SO RCS 27W D54 | In distribution | |
| SO RJP 26W D32 | In distribution | |
| SO LJG 30N D54 | In distribution | |
| SO RCM 21N D34 | In distribution | |
| SO LP 30 D55 | In distribution | |
| SO LCT 23N D34 | In distribution | |
| SO LCS 21N D12 | In distribution | |
| SO LTG 25N D56 | In distribution | |
| SO LJM 24N D55 | In distribution | |
| SO LCP 25N D54 | In distribution | |
| SO LJP 27N D54 | In distribution | |
| SO RTG 21N D54 | In distribution | |
| SO LT 26 D34 | In distribution | |
| SO RJP 28W D12 | In distribution | |
| SO RBP 26N D56 | In distribution | |
| SO RJG 23N D12 | In distribution | |
| SO RCP 29W D12 | In distribution | |
| SO RS 29 D32 | In distribution | |
| SO LJM 29W D33 | In distribution | |
| SO RCM 27N D12 | In distribution | |
| SO RCP 29W D34 | In distribution | |
| SO RCM 25N D54 | In distribution | |
| SO LCM 29N D54 | In distribution | |
| SO RCP 24W D32 | In distribution | |
| SO LBM 24N D54 | In distribution | |
| SO LJS 22N D11 | In distribution | |
| SO RJM 28N D54 | In distribution | |
| SO RJP 25W D34 | In distribution | |
| SO LJM 29W D54 | In distribution | |
| SO LJT 22N D32 | In distribution | |
| SO RBT 23N D34 | In distribution | |
| SO RTM 27N D12 | In distribution | |
| SO RJM 28N D53 | In distribution | |
| SO LJS 28W D55 | In distribution | |
| SO RBM 22N D54 | In distribution | |
| SO RBP 23N D32 | In distribution | |
| SO LBT 25W D33 | In distribution | |
| SO RM 25 D32 | In distribution | |
| SO LTT 27N D55 | In distribution | |
| SO RTG 28N D11 | In distribution | |
| SO LBP 27W D53 | In distribution | |
| SO LCS 28W D12 | In distribution | |
| SO LBT 29W D33 | In distribution | |
| SO LS 29 D32 | In distribution | |
| SO LCT 27W D34 | In distribution | |
| SO RCP 27W D32 | In distribution | |
| SO RTS 21N D33 | In distribution | |
| SO RTP 26N D34 | In distribution | |
| SO RM 30 D34 | In distribution | |
| SO LCM 26W D56 | In distribution | |
| SO LJG 29N D11 | In distribution | |
| SO LTP 25W D55 | In distribution | |
| SO RJT 24W D55 | In distribution | |
| SO LTP 29N D53 | In distribution | |
| SO RTT 27N D11 | In distribution | |
| SO RJP 29N D53 | In distribution | |
| SO LCT 27N D33 | In distribution | |
| SO RTG 29N D54 | In distribution | |
| SO LTM 21N D34 | In distribution | |
| SO LTT 29N D34 | In distribution | |
| SO LBM 29N D11 | In distribution | |
| SO LJG 26W D54 | In distribution | |
| SO LJM 23N D55 | In distribution | |
| SO LBS 27W D54 | In distribution | |
| SO LBT 30W D12 | In distribution | |
| SO LCT 25W D54 | In distribution | |
| SO LJM 28N D55 | In distribution | |
| SO LTM 27W D34 | In distribution | |
| SO RJT 30N D53 | In distribution | |
| SO RJS 28W D33 | In distribution | |
| SO RP 27 D12 | In distribution | |
| SO LCT 29W D11 | In distribution | |
| SO LJG 26W D34 | In distribution | |
| SO RBM 25N D54 | In distribution | |
| SO RCS 26W D12 | In distribution | |
| SO RJM 30N D55 | In distribution | |
| SO LCT 29W D55 | In distribution | |
| SO LCM 25W D56 | In distribution | |
| SO LTG 27W D33 | In distribution | |
| SO LTP 30N D54 | In distribution | |
| SO LBS 30W D55 | In distribution | |
| SO RG 28 D54 | In distribution | |
| SO RM 30 D54 | In distribution | |
| SO LTP 25W D75 | In distribution | |
| SO RBG 28W D54 | In distribution | |
| SO LTS 30W D32 | In distribution | |
| SO LTT 27W D34 | In distribution | |
| SO RCS 28N D34 | In distribution | |
| SO RJP 23N D55 | In distribution | |
| SO LBP 29W D11 | In distribution | |
| SO LJG 24W D33 | In distribution | |
| SO RJS 25W D54 | In distribution | |
| SO LTT 27W D55 | In distribution | |
| SO LCP 30N D54 | In distribution | |
| SO LBT 27W D12 | In distribution | |
| SO LM 22 D11 | In distribution | |
| SO RP 30 D34 | In distribution | |
| SO LCM 22N D12 | In distribution | |
| SO RBT 28W D11 | In distribution | |
| SO RJM 22N D12 | In distribution | |
| SO RTP 24N D34 | In distribution | |
| SO LCS 29W D53 | In distribution | |
| SO LCM 27W D12 | In distribution | |
| SO RTP 21N D34 | In distribution | |
| SO LJG 25W D32 | In distribution | |
| SO RBM 30N D34 | In distribution | |
| SO LCT 26N D34 | In distribution | |
| SO LTP 22N D55 | In distribution | |
| SO LCP 30W D55 | In distribution | |
| SO RBS 25W D33 | In distribution | |
| SO RTP 30N D11 | In distribution | |
| SO RJM 27W D34 | In distribution | |
| SO RCM 21N D12 | In distribution | |
| SO RTP 25W D76 | In distribution | |
| SO LS 22 D54 | In distribution | |
| SO RTS 25N D55 | In distribution | |
| SO LG 28 D54 | In distribution | |
| SO LJG 23N D34 | In distribution | |
| SO LJP 29N D12 | In distribution | |
| SO LTM 28W D34 | In distribution | |
| SO LTP 26N D12 | In distribution | |
| SO RTT 24N D55 | In distribution | |
| SO RCS 27W D55 | In distribution | |
| SO RTT 28W D53 | In distribution | |
| SO LM 23 D34 | In distribution | |
| SO LJP 22N D34 | In distribution | |
| SO RBP 29N D54 | In distribution | |
| SO RBS 26W D32 | In distribution | |
| SO LTG 29N D33 | In distribution | |
| SO LCT 25W D55 | In distribution | |
| SO RJP 21N D34 | In distribution | |
| SO RS 24 D54 | In distribution | |
| SO LTM 29W D34 | In distribution | |
| SO LP 26 D76 | In distribution | |
| SO LT 29 D53 | In distribution | |
| SO LCS 28N D53 | In distribution | |
| SO LJM 26N D12 | In distribution | |
| SO RBP 29N D32 | In distribution | |
| SO RCP 26N D32 | In distribution | |
| SO RTG 24N D33 | In distribution | |
| SO LT 22 D34 | In distribution | |
| SO RJT 28W D53 | In distribution | |
| SO RTG 26N D32 | In distribution | |
| SO RJP 24W D33 | In distribution | |
| SO RCG 27W D34 | In distribution | |
| SO LJG 28N D33 | In distribution | |
| SO RCP 30W D55 | In distribution | |
| SO LBM 25W D33 | In distribution | |
| SO RCM 22N D33 | In distribution | |
| SO LJT 25W D12 | In distribution | |
| SO RS 24 D55 | In distribution | |
| SO RBP 30W D32 | In distribution | |
| SO LBS 28W D55 | In distribution | |
| SO LJM 29W D11 | In distribution | |
| SO LCS 30W D55 | In distribution | |
| SO LBT 25W D55 | In distribution | |
| SO LJP 26N D55 | In distribution | |
| SO LTM 28N D54 | In distribution | |
| SO RTS 26W D55 | In distribution | |
| SO RTM 30W D34 | In distribution | |
| SO RBS 26W D33 | In distribution | |
| SO RTT 25W D55 | In distribution | |
| SO RJG 25W D75 | In distribution | |
| SO RBP 23N D34 | In distribution | |
| SO RJG 27W D55 | In distribution | |
| SO LBG 25N D12 | In distribution | |
| SO RJM 26N D33 | In distribution | |
| SO RTT 24W D11 | In distribution | |
| SO LBG 26W D34 | In distribution | |
| SO LTG 30N D33 | In distribution | |
| SO RJS 30N D11 | In distribution | |
| SO LCG 28N D34 | In distribution | |
| SO LTP 21N D55 | In distribution | |
| SO RTS 24N D54 | In distribution | |
| SO RJM 25W D75 | In distribution | |
| SO RJT 22N D11 | In distribution | |
| SO RBP 30W D55 | In distribution | |
| SO LBT 24N D33 | In distribution | |
| SO LBM 24N D34 | In distribution | |
| SO RJM 25N D75 | In distribution | |
| SO RJP 22N D33 | In distribution | |
| SO LJS 27N D34 | In distribution | |
| SO LJS 28W D53 | In distribution | |
| SO LBM 26W D56 | In distribution | |
| SO LBM 28N D55 | In distribution | |
| SO RJS 29W D54 | In distribution | |
| SO LS 26 D34 | In distribution | |
| SO RCM 29N D11 | In distribution | |
| SO RJM 24N D55 | In distribution | |
| SO RJP 28W D11 | In distribution | |
| SO LTG 30N D11 | In distribution | |
| SO RJP 27N D32 | In distribution | |
| SO LCT 21N D33 | In distribution | |
| SO LJM 21N D11 | In distribution | |
| SO RJM 27W D32 | In distribution | |
| SO LTG 25W D32 | In distribution | |
| SO LTP 27N D53 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.