Model: 5*5 snap
Catalog: 50*50mm*4
DI: 06976378040082
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
TENS/EMS Electrode Pads
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
39f36bee-8a39-4a17-88a6-d49675d2b52f
Distribution Status:
In Commercial Distribution
DUNS Number:
554408363
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06976378040082
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35995
Name: Transcutaneous electrical stimulation electrode, single-use
Definition:
An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.
FDA Product Codes
GXY
Electrode, Cutaneous
Premarket Submissions
Submission Number:
K181234
Supplement Number:
000