# K973884: Elastic Mandibular Advancement - Titration (Ema-T) Appilance

- Pathway: 510(k) (Traditional)
- Applicant: Frantz Design, Inc.
- Decided: Jan 9, 1998 after 87 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K880956 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 1.

## Most influential descendants
- K103704: Remotely Controlled Mandibular Positioner, RCMP (2012), 0 descendants of its own

## Indications for use
Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space

Source page: https://510kreport.com/device/K973884
Methodology: https://510kreport.com/methodology