# DEN240014: ARC-EX System

- Pathway: De Novo (Direct)
- Applicant: Onward Medical, Inc.
- Decided: Dec 19, 2024 after 266 days
- Product code: SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation)
- Device class: 2
- Regulation: 21 CFR 890.5851
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K253638: xStep (xStep) (2026), 0 descendants of its own
- K252893: ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (2026), 0 descendants of its own
- K251821: ARC-EX System (2025), 0 descendants of its own

## Indications for use
The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

Source page: https://510kreport.com/device/DEN240014
Methodology: https://510kreport.com/methodology