# K130158: M-SCAN

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Research Associates, Inc.
- Decided: Jul 25, 2013 after 183 days
- Product code: KZM (Device, Muscle Monitoring)
- Device class: 2
- Regulation: 21 CFR 890.1375
- 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 K003176 (2001). 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)
- K082927: Bioemg Iii, Bio-Research Associates, Inc. (2009) Summary page 1.

## Indications for use
Indications for use: 2 channel, hand held, mobile EMG amplifier 1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter 2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system 3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest 4. To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

Source page: https://510kreport.com/device/K130158
Methodology: https://510kreport.com/methodology