Neuromuscular Stimulator And Exercise Evaluation System
SDX · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1871
Classification
FDA Product Code
SDX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1871
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.