WellnessPro 2010 Plus

GUDID 00861284002605

ELECTRO MEDICAL TECHNOLOGIES, LLC

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