TENSPRODUCTS/TENSTRODE

Basic Information

• Brand Name: TENSPRODUCTS/TENSTRODE
• Primary DI: 00816924020129
• Version / Model: KWF46
• Catalog Number: KWF46-TP, KWF46-MFR, KWF46-JETT
• Company Name: Tensproducts, LLC
• Labeler DUNS: 104307787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-12
• Public Version: 4
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 49f4fe9b-ce0b-4ac7-aa73-cdc67f02f1b9

Device Description

4" X 6" BUTTERFLY WHITE FOAM ELECTRODE 1/PK

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
Package	30816924020120	GS1	Case	240	In Commercial Distribution
Primary	00816924020129	GS1
Package	10816924020126	GS1	Inner box	30	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K083302	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity