DeviceClearance

Product code SDX— Neurology

Myocene

Classification name
Neuromuscular Stimulator And Exercise Evaluation System
Device class
Class 2
Regulation
21 CFR 882.1871
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.”

— U.S. Food and Drug Administration, device classification record for product code SDX under 21 CFR 882.1871, via openFDA

Market context for product code SDX

FDA has cleared 1 device under product code SDX, all in 2025, filed by 1 applicant company. 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.

Top applicants under product code SDX

Recent clearances under product code SDX

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