E-Stim II ED3922

GUDID 14897076720030

The E-Stim II® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions.

TENS PLUS INDUSTRIAL COMPANY

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 14897076720030
• NIH Device Record Key: 25513770-e2a7-4284-bcda-cd1788ea219a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Stim II
• Version Model Number: ED3922
• Catalog Number: ED3922
• Company DUNS: 663211978
• Company Name: TENS PLUS INDUSTRIAL COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com
• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	14897076720030 [Primary]
GS1	34897076720034 [Package]; Package: Master Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050435

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-04

Devices Manufactured by TENS PLUS INDUSTRIAL COMPANY

• 14897076721457 - Lion.Warm.XL: 2023-06-13
• 14897076721655 - Multi.D.1.5: 2023-06-13
• 14897076721815 - Moxa.Bx.BamS: 2023-06-13
• 14897076721822 - Moxa.Bx.BamL: 2023-06-13
• 14897076721853 - Pistol: 2023-06-13
• 14897076721860 - Pistol.Long: 2023-06-13
• 14897076721877 - Ins.MP.S: 2023-06-13
• 14897076721884 - Ins.MP.M: 2023-06-13