# K980363: Oro-Facial Myographic Measurement Instrument (Ommi)

- Pathway: 510(k) (Traditional)
- Applicant: Orofacial Dynamics
- Decided: Apr 16, 1998 after 77 days
- Product code: LBB (Dynamometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 888.1240
- 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 K964685 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964685: Dynamometer, John Chatillon & Sons, Inc. (1997) Summary page 2.

## Indications for use
The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.

Source page: https://510kreport.com/device/K980363
Methodology: https://510kreport.com/methodology