Myocene Electrode 1

• FDA 510(k) K132998 decided 20 Dec 2013 Active
• FDA GUDID UDI-DI 05430004268017 listed 24 Apr 2025 Listed

1. 20 Dec 2013 Cleared FDA 510(k) K132998
2. 24 Apr 2025 Listed FDA GUDID 05430004268017

Trade name

Myocene Electrode

Generic name

Transcutaneous electrical stimulation electrode, reusable

Model / reference

1

Primary DI / UDI-DI

05430004268017

510(k) Number

K132998 ↗

FDA product code

GXY

GMDN term

Transcutaneous electrical stimulation electrode, reusable

Device class

Class II

Regulation number

882.1320

GUDID distribution status

In Commercial Distribution

Category: Transcutaneous electrical stimulation electrode, reusable

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

• PROGEL(TM), MODELS 8630 AND 8635 by Medical Devices, Inc.
• CANMED 103 9300 ELECTRODE by MEDTRONIC VASCULAR, INC.
• ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 by Aspect Medical Systems, Inc.
• LONG LIFE PADTM by Omron Healthcare, Inc.
• SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT by Labeltape Meditect, Inc.
• BIS BILATERAL SENSOR by Aspect Medical Systems, Inc.
• POST-OP ELECTRODE (TENS ELECTRODE) by Consolidated Medical Equipment, Inc.
• connectgrip. 560X27-1=IOS by Otto Bock Healthcare Products GmbH
• DISPOSABLE ELECTRODE by Sanibel Supply
• Sanibel Tab electrode by Interacoustics A/S

• Myocene 1-U

  Class II

  GUDID on market

• Myocene

  Class II

  FDA De Novo DEN230051 Active Cleared 17 Jan 2025 FDA 510(k)