# K971318: MM-1 Movement Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Axon Instruments, Inc.
- Decided: Jul 28, 1997 after 110 days
- Product code: GYD (Transducer, Tremor)
- Device class: 2
- Regulation: 21 CFR 882.1950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices 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.

## Most influential descendants
- K140086: Personal Kinetigraph (PKG) System (2014), 9 descendants of its own
- K213519: Rune Labs Tremor Transducer System (2022), 4 descendants of its own
- K220820: Parky App (2022), 3 descendants of its own
- K161717: Personal Kinetigraph (PKG) System (2016), 3 descendants of its own
- K250153: Neu Platform (2025), 1 descendant of its own

## Indications for use
The MM-1 provides useful, quantitative measurements of several neurclogically relevant movciment phenomena: tremor, dexterity and reaction/movemerit time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.

Source page: https://510kreport.com/device/K971318
Methodology: https://510kreport.com/methodology