ST FS10011

GUDID 07290016681277

Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments

FORMATK SYSTEMS LTD

Radio-frequency skin contouring system applicator, bipolar

• Primary Device ID: 07290016681277
• NIH Device Record Key: 0a7abea0-d7a5-473d-a9e6-f1f4266ddf9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST
• Version Model Number: FS10011
• Catalog Number: FS10011
• Company DUNS: 532396673
• Company Name: FORMATK SYSTEMS LTD
• 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: false
• 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	07290016681277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160195

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-18

Devices Manufactured by FORMATK SYSTEMS LTD

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