Three degrees

Basic Information

• Brand Name: Three degrees
• Primary DI: 06976378040006
• Version / Model: Rectangular
• Company Name: Dong Guan Ou Kang Electronics CO.,LTD
• Labeler DUNS: 554408363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 133247bf-e895-4586-8d21-46c3de145791

Device Description

Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40, 20*80, 20*100, 25*35, 30*50, 30*60, 30*70, 30*90, 32*95, 35*45, 35*50, 35*70, 35*82, 40*53, 40*60, 40*70, 40*90, 40*100, 45*60, 45*70, 45*90, 45*95, 46*73, 50*55, 50*60, 50*70, 50*80, 50*90, 50*100, 52*78, 53*210, 55*90, 50*96, 55*100, 60*70, 60*80, 60*90, 60*100, 62*96, 65*140, 68*88, 70*70, 70*100, 70*110, 70*130, 70*140, 73*160, 90*130, 95*100, 95*195, 96*162, 98*220, 100*150, 110*150, 115*180, 150*200.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35995	Transcutaneous electrical stimulation electrode, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06976378040006	GS1

Premarket Submissions

Submission Number	Supplement Number
K181234	000