Pointer Excel II ED3988

GUDID 14897076720054

Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions.

TENS PLUS INDUSTRIAL COMPANY

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 14897076720054
• NIH Device Record Key: 029d0ad0-aff2-46df-94db-78d4622119f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointer Excel II
• Version Model Number: ED3988
• Catalog Number: ED3988
• 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	14897076720054 [Primary]
GS1	34897076720058 [Package]; Package: Master Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060517

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

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