Data / Medical devices / Foot Wrap For Treating Restless Leg Syndrome Symptoms
Foot Wrap For Treating Restless Leg Syndrome Symptoms (OTX): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Foot Wrap For Treating Restless Leg Syndrome Symptoms (product code OTX, Class 1, 21 CFR 890.5760). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on December 18, 2013, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OTX
- Device class
- 1
- Regulation
- 890.5760
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 4 |
| Vietnam | 1 |
Makers of Foot Wrap For Treating Restless Leg Syndrome Symptoms
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 |
|---|---|---|---|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou New Design Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi MFG., Inc. | Whitsett, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi Usa, LP | Whitsett, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Just Soon Industrial Limited | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesla Biohealing, Inc. | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Steriger Sports Medicine Technology Co.,Ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 18, 2013. 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.