# K010270: Tremorometer

- Pathway: 510(k) (Traditional)
- Applicant: Flexable Systems, Inc.
- Decided: Jul 25, 2001 after 177 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Axiom: named in the summary without a submission number
- (no number) FlexiPlus™: named in the summary without a submission number
- (no number) Actiwatch®: named in the summary without a submission number

## Most influential descendants
- K063872: Kinesia (2007), 10 descendants of its own
- 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

## Indications for use
The Tremorometer is designed to be used to measure and record tri-axial readings of a patient’s tremor motions, to optionally combine the three axis tremor information into a single measurement of total tremor movement by a proprietary algorithm that eliminates some of the rotational, orientation and other artifacts, to display the information graphically, and to transfer the data to a PC for further analysis, display, printing or storage.

Source page: https://510kreport.com/device/K010270
Methodology: https://510kreport.com/methodology