Revitive Medic Plus 3158

GUDID 10858058005143

Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation Device

ACTEGY LIMITED

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10858058005143
• NIH Device Record Key: e09df9e4-1eee-4758-b647-7009c2c3f1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revitive Medic Plus
• Version Model Number: 3156AD
• Catalog Number: 3158
• Company DUNS: 735575941
• Company Name: ACTEGY LIMITED
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8772603114
• Email: us.info@actegy.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858058005146 [Primary]
GS1	10858058005143 [Package]; Contains: 00858058005146; Package: Outer carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190924

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

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: 2019-10-09

Devices Manufactured by ACTEGY LIMITED

• 10858058005228 - Revitive Medic Coach: 2022-02-07 Neuromuscular Electrical Stimulation Device
• 10858058005044 - Aerosure: 2021-05-12
• 05060217492130 - Revitive Electrode Body Pads: 2021-05-12
• 10858058005259 - Revitive ProHealth: 2021-01-29 Neuromuscular Electrical Stimulation Device
• 10858058005235 - Revitive Medic: 2021-01-27 Neuromuscular Electrical Stimulation Device
• 10858058005105 - Revitive Essential: 2020-10-02 Neuromuscular Electrical Stimulation Device
• 10858058005181 - Revitive Medic Knee: 2020-10-02 Neuromuscular Electrical Stimulation Device
• 05060217493588 - Revitive Arthritis Knee Pads: 2020-08-05 Revitive Arthritis Knee Pads