510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN230051Unknown

Myocene

Myocene, Liège, BE / Direct, Unknown
FDA source (opens on fda.gov)

DEN230051 is the FDA 510(k) clearance record for Myocene, a class II device, cleared for Myocene on under FDA product code SDX (Neuromuscular Stimulator And Exercise Evaluation System). FDA's definition for product code SDX 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...". FDA records list one 510(k) clearance for Myocene. As of , FDA records show no recalls naming DEN230051.

Clearance record

Decision date
Received
(540 days to decision)
Product code
SDX Neuromuscular Stimulator And Exercise Evaluation System
Regulation
21 CFR 882.1871
Device class
Class II
Review panel
Neurology
Applicant
Myocene Quai Banning 6, Liège, BE
Third party review
No

Clearances, product code SDX

Trailing 12 months

FDA records hold no clearances under product code SDX in the trailing twelve months.

FDA records show no clearances under product code SDX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260