# K970116: Esg-1 Electrosonogram (Esg-1)

- Pathway: 510(k) (Traditional)
- Applicant: Myo-Tronics, Inc.
- Decided: Apr 2, 1997 after 79 days
- Product code: NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds)
- Device class: 1
- Regulation: 21 CFR 872.2050
- 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. The FDA summary names its predicate without a number.
- (no number) Sonopak/QS: named in the summary without a submission number

## Indications for use
The ELECTROSONOGRAM ESG-1 is a noninvasive device that measures and records sounds emitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.

Source page: https://510kreport.com/device/K970116
Methodology: https://510kreport.com/methodology