The following data is part of a premarket notification filed by Eswallow Usa with the FDA for Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy Kit.
| Device ID | K092202 |
| 510k Number | K092202 |
| Device Name: | ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ESWALLOW USA 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ESWALLOW USA 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2011-02-10 |
| Summary: | summary |