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510(k) DEN240014

ARC-EX System by Onward Medical, Inc. — Product Code SDO

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 19, 2024
Date Received
March 28, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class
Class II
Regulation Number
890.5851
Review Panel
PM
Submission Type

A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.

Other clearances by Onward Medical, Inc.

  • K251821 — ARC-EX System (November 14, 2025)

Other clearances for product code SDO

  • K252893 — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); Re (March 27, 2026)
  • K251821 — ARC-EX System (November 14, 2025)