Data / Medical devices / Orthosis, Moldable, Supportive, Skin Protective
Orthosis, Moldable, Supportive, Skin Protective (MNE): 19 FDA-registered makers in 9 countries
19 establishments in 9 countries are registered with the FDA to make Orthosis, Moldable, Supportive, Skin Protective (product code MNE, Class 1, 21 CFR 890.3475). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 29, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MNE
- Device class
- 1
- Regulation
- 890.3475
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 3 |
| Germany | 1 |
| Israel | 1 |
| Egypt | 1 |
| Belgium | 1 |
| Canada | 1 |
| South Korea | 1 |
| Mexico | 1 |
Makers of Orthosis, Moldable, Supportive, Skin Protective
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Crown Delta Corp. | Yorktown, NY, United States | Manufacturer | 1 | September 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Brilliant Health Solutions, Inc. | Centerville, TN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreve Otoplastik GmbH | UNNA North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gd-Stride Ltd | Jerusalem, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Xinbo Electronic Co., Ltd | guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Zhicheng Health Technology Co.,ltd | Yingtan Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orfit Industries NV | WIJNEGEM Antwerpen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orpyx Medical Technologies Inc. | Calgary Alberta, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Partnership Fabrication Systems FAS LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S & F Inc | Buk-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jiding Electronic Co.,ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suichang Xiangdong Industry and Trading Co., Ltd. | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Magique Huaer Biotech Co.,ltd. | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 29, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.