USA 40x100 Body Clock Branded Electrodes

Basic Information

• Brand Name: USA 40x100 Body Clock Branded Electrodes
• Primary DI: B364792117400
• Version / Model: Electrodes Size 40 x 100mm
• Company Name: BODY CLOCK HEALTH CARE LIMITED
• Labeler DUNS: 504712829
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-06
• Public Version: 7
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: bcd237b7-81a8-4044-89cf-b5c643400a34

Device Description

Indications for Use: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B364792117400	HIBCC

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius