DeviceClearance

Product code SDO— Physical Medicine

ARC-EX System

Classification name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device class
Class 2
Regulation
21 CFR 890.5851
Advisory panel
Physical Medicine
Total cleared
4
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SDO under 21 CFR 890.5851, via openFDA

Market context for product code SDO

FDA has cleared 4 devices under product code SDO between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SDO

Recent clearances under product code SDO

Data sourced from openFDA. This site is unofficial and independent of the FDA.