# K120922: Guardian Dysphagia Dual Channel Nmes Unit

- Pathway: 510(k) (Abbreviated)
- Applicant: Selectivemed Components, Inc.
- Decided: Feb 7, 2013 after 317 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: 4 generations back to K880235 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070425: Vitalstim Experia, Chattanooga Group (2007) Summary page 1.

## Indications for use
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

Source page: https://510kreport.com/device/K120922
Methodology: https://510kreport.com/methodology