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SDX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Neuromuscular Stimulator And Exercise Evaluation System
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1871
Medical specialty
Neurology
FDA 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.
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RecordFirmDate
Myocene (DEN230051)Myocene2025-01-17

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