# DEN110009: Foot Wrap For Treating Restless Leg Syndrome Symptoms

- Pathway: De Novo
- Applicant: unknown
- Decided: —
- Product code: OTX (Foot Wrap For Treating Restless Leg Syndrome Symptoms)
- Device class: 1
- Regulation: 21 CFR 890.5760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191933: COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (2019), 0 descendants of its own

Source page: https://510kreport.com/device/DEN110009
Methodology: https://510kreport.com/methodology