Eswallow USA
Naples, FL, US
Eswallow USA appears in FDA device records in Naples, FL. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Eswallow USA between 2011 and 2013. The busiest year on record is 2011, with 1. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2880-2011 | eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia. | It was discovered that the firm was distributing medical devices without FDA approval. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain