# K131222: Ampcare Esp Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Ampcare, LLC
- Decided: Oct 31, 2013 after 184 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AMPCARE ES PTM system uses the AMPCARE ESTM stimulator in combination with the AMPCARE ES electrodes, The AMPCARE ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. AMPOARE ES cutaneous electrodes are indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Source page: https://510kreport.com/device/K131222
Methodology: https://510kreport.com/methodology