WellnessPro 2010 Plus

GUDID 00861284002605

ELECTRO MEDICAL TECHNOLOGIES, LLC

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

• Primary Device ID: 00861284002605
• NIH Device Record Key: d13cbf9f-8465-4781-9f1f-88bac1dc895e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WellnessPro
• Version Model Number: 2010 Plus
• Catalog Number: 2010 Plus
• Company DUNS: 160641309
• Company Name: ELECTRO MEDICAL TECHNOLOGIES, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861284002605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062616

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: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-06-23

On-Brand Devices [WellnessPro]

• 00861284002605: 2010 Plus
• B243SSWP2010PLUS0: Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed to pr