Doctor Tecar Smart

GUDID 08051499970871

Doctor Tecar Smart is a diathermy product. This therapy increases the temperature in the body areas under treatment by means of a particular electric current, restoring the natural reparative capacity of the body. The dual delivery modes, capacitive and resistive, allow setting a specific treatment based on the disease to be cured, thus regenerating the tissues in depth.

MECTRONIC MEDICALE SRL

Medium-wave diathermy treatment system

• Primary Device ID: 08051499970871
• NIH Device Record Key: afda3a10-28a7-4849-93e1-d7ff635eb415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doctor Tecar Smart
• Version Model Number: 1.1
• Company DUNS: 429098838
• Company Name: MECTRONIC MEDICALE SRL
• 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: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it
• Phone: +39035656080
• Email: info@mectronicmedicale.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051499970871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221043

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: 2023-03-08
• Device Publish Date: 2023-02-28

Devices Manufactured by MECTRONIC MEDICALE SRL

• 08051499971007 - CHELT F EB 60: 2024-12-06 CHELT is a medical device for laser and cryo therapy, designed to provide topical heating for the purpose of elevating tissues t
• 08051499974084 - iLux LF D12: 2024-12-06 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499974107 - iLux LF D25: 2024-12-06 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499970758 - Ixyon XP F50 ED: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499970765 - Ixyon XP F92 OA: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971304 - iLux LF Y10: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971328 - iLux LF HPS Y15: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur
• 08051499971335 - iLux LF HPS D10: 2024-10-18 The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperatur