510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SDXClass II

Neuromuscular Stimulator And Exercise Evaluation System

21 CFR 882.1871 / Neurology
FDA source (opens on fda.gov)

SDX is the FDA product code for Neuromuscular Stimulator And Exercise Evaluation System, a class II device type, regulated under 21 CFR 882.1871. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SDX
Device name
Neuromuscular Stimulator And Exercise Evaluation System
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.
Regulation
21 CFR 882.1871
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SDX

By decision year
1 clearance under product code SDX with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDX by decision year
YearClearances
20251

Applicants with the most clearances

Product code SDX
Applicants holding the most 510(k) clearances under product code SDX
ApplicantClearances
Myocene1

Companies listing this code with FDA

Companies whose registered establishments list this code