# K082927: Bioemg Iii

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Research Associates, Inc.
- Decided: Feb 6, 2009 after 128 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: 1 generation back to K003176 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003176: Bioemg II and Biojva, Bio-Research Associates, Inc. (2001) Summary page 1.

## Most influential descendants
- K130158: M-SCAN (2013), 0 descendants of its own

## Indications for use
Indications for use: 8 channel EMG amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric 2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system 3. To determine the degree of relaxation.(intra-patient) of a single muscle/ group of muscles at rest 4. To measure relative (intra-patient) levels of activity of several muscles during a functional act Indications for Use: 2 channel JVA amplifier 1. To record and display sounds /vibrations from the temporomandibular joints 2. To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the waveform in various standard plots (together with K981563). 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during and after treatment 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds /vibrations, allowing intra-patient comparisons (only) by the clinician

Source page: https://510kreport.com/device/K082927
Methodology: https://510kreport.com/methodology