# K251821: ARC-EX System

- Pathway: 510(k) (Traditional)
- Applicant: Onward Medical, Inc.
- Decided: Nov 14, 2025 after 154 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
Longest line of descent: 1 generation back to DEN240014 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240014: ARC-EX System, Onward Medical, Inc. (2024) Summary page 5.

## Indications for use
The ARC-EX System is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home 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). The ARC-EX System is intended to be operated in medical centers by Rehabilitation Professionals and at home by Patients and Persons Providing Assistance to the Patient as needed.

Source page: https://510kreport.com/device/K251821
Methodology: https://510kreport.com/methodology