ES-160

Basic Information

• Brand Name: ES-160
• Primary DI: 04983087008496
• Version / Model: ES-160
• Catalog Number: ES-160
• Company Name: ITO CO., LTD.
• Labeler DUNS: 690637194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2021-12-07
• Public Version Status: Update
• Public Device Record Key: 947bf6ee-f48b-4ed2-a4aa-a2d9d9404727

Device Description

Electro Stimulator Therapy Unit

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13763	Acupuncture electrical stimulation system	An electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04983087008496	GS1
Package	24983087008490	GS1		5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K051020	000