# K992694: Modification to K6-I Diagnostic System, Model K6-I

- Pathway: 510(k) (Special)
- Applicant: Myotronics-Noromed, Inc.
- Decided: Sep 10, 1999 after 29 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“15425”).
- (no number) ProComp DSP & ProComp: named in the summary without a submission number
- (no number) Myosystem 1000 Electromyograph: named in the summary without a submission number
- (no number) I-330 Physiological Monitor: named in the summary without a submission number

## Most influential descendants
- K030869: Bitestrip (2004), 3 descendants of its own
- K092675: Grindcare (2010), 2 descendants of its own
- K163448: GrindCare System (2017), 0 descendants of its own
- K113677: Grindcare Measure (2012), 0 descendants of its own

## Indications for use
For Jaw Tracking functions of this device: Tracks mandibular movement and position For the diagnosis of functional disorders such as TMJJMPD syndrome, muscle tension, bruxing, and instability of occlusion Identification of mandibular rest position Identification of interocclusal distance and freeway space Monitors the position of the jaw in three dimensions Represents the spatial position of the mandibular incisal edge relative to the skull For electromvonrauhic function of this device: Intended for use for muscles of mastication, especially temporalis, masseter, and digastric Designed to perform a limited number of functions in dental diagnosis For use as a stand alone system for clinical monitoring of up to eight different muscles. it is ideally suited for diagnosis and treatment evaluation by recording function/dysfunction of the muscles of the stomatognathic system The determination of the degree of relaxation of a particular muscle or muscle group at rest The precise measurement of relative levels of contraction of several muscles during a functional test For both functions of this device: Diagnosis and management of TMJIMPD disorders, orthodontic patients, denture patients, and reconstruction patients.

Source page: https://510kreport.com/device/K992694
Methodology: https://510kreport.com/methodology