Breeze
Breeze Foot, Right, Caucasian, Endo IP, 22cm, Category 3
14manufacturers in China registered for this device type
70catalogue 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 | 2023-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BE LCEN 21 D3 | In distribution | |
| BE LBEN 22 D3 | In distribution | |
| BE RTEN 30 D3 | In distribution | |
| BE LTEN 26 D3 | In distribution | |
| BE RCEN 22 D3 | In distribution | |
| BE RTEN 21 D3 | In distribution | |
| BE RTEN 26 D3 | In distribution | |
| BE LCEN 22 D3 | In distribution | |
| BE RBEN 30 D3 | In distribution | |
| BE RBEN 25 D3 | In distribution | |
| BE EN 30 D3 | In distribution | |
| BE LBEN 28 D3 | In distribution | |
| BE LTEN 27 D3 | In distribution | |
| BE RBEN 21 D3 | In distribution | |
| BE RBEN 29 D3 | In distribution | |
| BE LCEN 24 D3 | In distribution | |
| BE LBEN 26 D3 | In distribution | |
| BE RCEN 24 D3 | In distribution | |
| BE LTEN 22 D3 | In distribution | |
| BE RBEN 24 D3 | In distribution | |
| BE EN 25 D3 | In distribution | |
| BE LBEN 27 D3 | In distribution | |
| BE LCEN 27 D3 | In distribution | |
| BE LTEN 29 D3 | In distribution | |
| BE RTEN 28 D3 | In distribution | |
| BE RTEN 23 D3 | In distribution | |
| BE LBEN 29 D3 | In distribution | |
| BE LBEN 24 D3 | In distribution | |
| BE LBEN 25 D3 | In distribution | |
| BE RBEN 28 D3 | In distribution | |
| BE RTEN 25 D3 | In distribution | |
| BE LCEN 30 D3 | In distribution | |
| BE EN 28 D3 | In distribution | |
| BE LCEN 26 D3 | In distribution | |
| BE EN 23 D3 | In distribution | |
| BE LBEN 23 D3 | In distribution | |
| BE LCEN 25 D3 | In distribution | |
| BE RCEN 21 D3 | In distribution | |
| BE RBEN 23 D3 | In distribution | |
| BE LBEN 30 D3 | In distribution | |
| BE RCEN 29 D3 | In distribution | |
| BE LBEN 21 D3 | In distribution | |
| BE RBEN 22 D3 | In distribution | |
| BE EN 22 D3 | In distribution | |
| BE RBEN 27 D3 | In distribution | |
| BE RBEN 26 D3 | In distribution | |
| BE RCEN 25 D3 | In distribution | |
| BE RTEN 22 D3 | In distribution | |
| BE LCEN 28 D3 | In distribution | |
| BE RTEN 24 D3 | In distribution | |
| BE RCEN 23 D3 | In distribution | |
| BE LTEN 24 D3 | In distribution | |
| BE RCEN 28 D3 | In distribution | |
| BE LCEN 23 D3 | In distribution | |
| BE RTEN 27 D3 | In distribution | |
| BE LTEN 23 D3 | In distribution | |
| BE LTEN 28 D3 | In distribution | |
| BE LCEN 29 D3 | In distribution | |
| BE RTEN 29 D3 | In distribution | |
| BE EN 24 D3 | In distribution | |
| BE EN 27 D3 | In distribution | |
| BE EN 29 D3 | In distribution | |
| BE RCEN 27 D3 | In distribution | |
| BE LTEN 30 D3 | In distribution | |
| BE EN 21 D3 | In distribution | |
| BE LTEN 25 D3 | In distribution | |
| BE RCEN 26 D3 | In distribution | |
| BE EN 26 D3 | In distribution | |
| BE LTEN 21 D3 | In distribution | |
| BE RCEN 30 D3 | In distribution |
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 |
| Odyssey K3 | College Park Industries | 450 |
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.