Apollo Duet

GUDID 08809851470015

Pain management device with multipolar RF

WEERO Co.

Radio-frequency physical therapy system

• Primary Device ID: 08809851470015
• NIH Device Record Key: c4093711-6a6a-45cf-9d79-345e0273985e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Duet
• Version Model Number: ADP-4000
• Company DUNS: 695596573
• Company Name: WEERO Co.
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809851470015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212253

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-21
• Device Publish Date: 2023-03-13