Eswallow USA
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Eswallow USA makes
Eswallow USA manufactures electrodes and leadwires for medical use, as well as dysphagia therapy kits designed to assist patients with swallowing difficulties. The electrode and leadwire products are likely intended for diagnostic or therapeutic procedures involving electrical stimulation or monitoring. The dysphagia therapy kits include components for oral motor exercises and swallowing rehabilitation.
The company’s products are classified as Class II medical devices under FDA regulations, with authorisation supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database. Eswallow USA is based in the United States.
Catalogue
Eswallow Usa Electrode, Eswallow Usa Leadwire Ref K113375
510(k) 510(k)- 510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Eswallow USA, initiated on 2011-06-22. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 22 Jun 2011 Z-2880-2011 Unclassified (pre-2012) Terminated It was discovered that the firm was distributing medical devices without FDA approval.
Frequently asked questions
How many devices does Eswallow USA have in the registry?
The registry currently lists 2 devices for Eswallow USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eswallow USA's devices?
Among its 2 most recently registered devices, Eswallow USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Eswallow USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eswallow USA's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Eswallow USA?
FDA recall records list 1 recall initiated by Eswallow USA, the most recent initiated on 2011-06-22. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Eswallow USA in the registry?
The most recently registered devices listed for Eswallow USA include ESWALLOW USA ELECTRODE, ESWALLOW USA LEADWIRE and ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT.