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SDX

Neuromuscular Stimulator And Exercise Evaluation System

Product code
SDX
Device name
Neuromuscular Stimulator And Exercise Evaluation System
Device class
Class 2
21 CFR
21 CFR 882.1871
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-17.

NumberDecision dateApplicantDevice nameSummary
DEN2300512025-01-17MyoceneMyocene—
Official FDA classification page: SDX
Classification and pathway per current FDA publications. Data from openFDA (CC0).