Data / Medical devices / Electrosurgical Patient Return Electrode
Electrosurgical Patient Return Electrode (ODR): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Electrosurgical Patient Return Electrode (product code ODR, Class 2, 21 CFR 878.4400). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 19, 2016, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ODR
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Vietnam | 1 |
| Taiwan | 1 |
| Malaysia | 1 |
Makers of Electrosurgical Patient Return Electrode
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 |
|---|---|---|---|---|---|---|---|---|
| Mullan Medical (vietnam) Limited Company | Tu Son Bac Ninh, Vietnam | Manufacturer | 1 | August 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Top-rank Health Care Co.,Ltd. | Shaoxing Zhejiang, China | Manufacturer | 1 | August 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Wandy Rubber Industrial Co., Ltd | New Taipei City, Taiwan | Manufacturer | 1 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Britegums Inc. | Cary, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Diagnostics Incorporated | Plymouth, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shuyou Industrial Malaysia SDN.BHD. | GEORGE TOWN Perak, Malaysia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shuyou Surgical Instrument Co., Ltd | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 19, 2016. 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.