SDX — Neuromuscular Stimulator And Exercise Evaluation System Class II

FDA Device Classification

Classification Details

Product Code
SDX
Device Class
Class II
Regulation Number
882.1871
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN230051myoceneMyoceneJanuary 17, 2025