sensiFirm

GUDID 05060445341118

The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite

EL GLOBAL TRADE LTD

Radio-frequency skin surface treatment system

• Primary Device ID: 05060445341118
• NIH Device Record Key: 61606518-757b-481f-9b36-6ea176fe3a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sensiFirm
• Version Model Number: CEL100US01SNS
• Company DUNS: 649726981
• Company Name: EL GLOBAL TRADE 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: 855-736-7422
• Email: support@sensica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060445341118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170637

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-07
• Device Publish Date: 2017-08-16

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• 05060445340029 - SensiLight - salmon: 2020-02-07 The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for per
• 05060445340043 - SensiLight Mini - mint: 2020-02-07 The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intend
• 05060445340050 - SensiLight Mini - blue: 2020-02-07 The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intend
• 05060445341118 - sensiFirm: 2020-02-07The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
• 05060445341118 - sensiFirm: 2020-02-07 The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massag