Pointer Excel II

Basic Information

• Brand Name: Pointer Excel II
• Primary DI: 14897076720054
• Version / Model: ED3988
• Catalog Number: ED3988
• Company Name: TENS PLUS INDUSTRIAL COMPANY
• Labeler DUNS: 663211978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 029d0ad0-aff2-46df-94db-78d4622119f6

Device Description

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.

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: 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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14897076720054	GS1
Package	34897076720058	GS1	Master Case	30	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060517	000