# K182906: Portable Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Feellife Health, Inc.
- Decided: Sep 27, 2020 after 711 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. It is not intended for use with Pentamidine. Patient Population: Adult and Pediatric (older than 5 years of age). Environment of Use: Home healthcare.

Source page: https://510kreport.com/device/K182906
Methodology: https://510kreport.com/methodology