ZIONIC AESTHETIC A463AE

GUDID 08436601290526

TERMOSALUD SL

Medium-wave diathermy treatment system

• Primary Device ID: 08436601290526
• NIH Device Record Key: e5140319-e080-42df-9c20-3ee2c6c38474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIONIC AESTHETIC
• Version Model Number: ZIONIC AESTHETIC HP
• Catalog Number: A463AE
• Company DUNS: 470725128
• Company Name: TERMOSALUD SL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08436601290526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230659

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: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [ZIONIC AESTHETIC]

• 08436601290809: DEEP ACTION 30MM
• 08436601290793: DEEP ACTION MAX 19MM
• 08436601290526: ZIONIC AESTHETIC HP
• 08436601290519: ZIONIC AESTHETIC