Revitive Circulation Booster 1718

GUDID 10858058005013

Neuromuscular Electrical Stimulation Device

ACTEGY LIMITED

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 10858058005013
• NIH Device Record Key: bacec4a1-0e63-4b47-9107-784dd0cd585f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revitive Circulation Booster
• Version Model Number: RIX
• Catalog Number: 1718
• 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
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858058005016 [Primary]
GS1	10858058005013 [Package]; Contains: 00858058005016; Package: Outer carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143207

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-04-23

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