# K981563: Biopak Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Research Associates, Inc.
- Decided: Sep 15, 1998 after 137 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made. Sufficient normative data have not been collected to support such population-based measurements as “mean electromyographic clench,” “standard deviation (Jaw Tracking) of freeway space,” “integral (sonograph) of sound intensity,” “average jaw tracing of chewing,” etc., for non diseased individuals as well as for patients having various disease entities that are now lumped within the terminology known as ‘Temporomandibular Disorders and Associated Orofacial Pain (TMD/MPD)." Jaw Tracking 1. To track mandibular movement and position 2. To aid in the diagnosis of TMJ/ MPD syndrome, muscle tension and bruxing [instability of occlusion] 3 To identify mandibular rest position and to identify interocclusal distance and freeway space 4. To monitor the position of the jaw in three dimensions 5. To represent the spatial position of the mandibular incisal edge relative to the skull To provide Baseline measurements for future reference Electromyography 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 diagnosis and treatment evaluation by recording the electrical activity of the 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 To provide Baseline measurements for future reference Sonography, joint vibration (sound) recording 1. To record and display sounds / vibrations from the temporomandibular joint 2. To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots 3. To aid the clinician in comparing a patient’s current standard 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 5. To provide Baseline measurements for future reference

Source page: https://510kreport.com/device/K981563
Methodology: https://510kreport.com/methodology