# K092202: Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Eswallow USA
- Decided: Feb 10, 2011 after 568 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023347 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023347: Vital Stim, Chattanooga Group (2002) Summary page 1.

## Indications for use
This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Source page: https://510kreport.com/device/K092202
Methodology: https://510kreport.com/methodology