Pointer-Plus ED3332

GUDID 14897076720047

Pointer-Plus - Locator/Stim is a complete clinic in your hands. Modern, hand held, 6.5" long unit offers accurate acupuncture point stimulation with adjustable intensity dial. The pulse frequency is fixed at 10 Hz. The grounding circuit is made by holding the metal plate on the side of the unit or with the hand grounding pole. Accessories include 2 probe tips (ear 2 mm 0.08" and body 4 mm 0.16"), hand grounding pole with attached wire, 9 volt battery, carrying case, and instructions.

TENS PLUS INDUSTRIAL COMPANY

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 14897076720047
• NIH Device Record Key: f081b155-88ae-4aa7-aa46-5bc2b57c7abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointer-Plus
• Version Model Number: ED3332
• Catalog Number: ED3332
• 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	14897076720047 [Primary]
GS1	34897076720041 [Package]; Package: Master Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060508

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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