# K141380: Provox Freehands Flexivoice

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: Sep 26, 2014 after 122 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821568 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022125: Provox Freehands Hme, Model 7710, Atos Medical AB (2002) Summary page 4.

## Indications for use
The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis. The entire device is for single patient use and the HME-part is for single use, i.e, it has to be exchanged at least every 24 hours. Environments of use include: Hospitals, ICU, sub-acute care institutions and home.

Source page: https://510kreport.com/device/K141380
Methodology: https://510kreport.com/methodology