ZShape 5570

GUDID 04053815086369

Zimmer MedizinSysteme GmbH

Radio-frequency physical therapy system

• Primary Device ID: 04053815086369
• NIH Device Record Key: 5c904cb4-d2ac-4832-8f47-3b2f14768986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZShape
• Version Model Number: RFG-01
• Catalog Number: 5570
• Company DUNS: 316111251
• Company Name: Zimmer MedizinSysteme GmbH
• 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

Customer Support Contacts

• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053815086369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240178

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: 2024-07-29
• Device Publish Date: 2024-07-19

Devices Manufactured by Zimmer MedizinSysteme GmbH

• 04053815087410 - ZStim: 2024-08-06
• 04053815086369 - ZShape: 2024-07-29
• 04053815086369 - ZShape: 2024-07-29
• 04053815087229 - Cryo 7: 2024-06-04
• 04053815076711 - MFG-05: 2023-10-24
• 04053815081296 - ThermoTK: 2023-06-13
• 04053815083344 - clTrac: 2023-06-13
• 04053815078562 - emField: 2022-05-19
• 04053815080848 - Cryo 7: 2022-03-09