# K043138: Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134

- Pathway: 510(k) (Special)
- Applicant: Atos Medical AB
- Decided: Nov 22, 2004 after 10 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: 1 generation back to K821568 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971244: Provox 2 Voice Prosthesis System, Atos Medical AB (1997) Summary page 2.
- K821568: Blow-Singer Tracheostoma Valve, Bivona Medical Technologies (1982) Summary page 2.

## Indications for use
The Provox® NIDTM Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision. The Provox NID is intended for single patient use.

Source page: https://510kreport.com/device/K043138
Methodology: https://510kreport.com/methodology