Human Tecar 16476

GUDID 08056182721013

Straight Handpiece for Capacitive Electrodes (Metallic connection)

UNIBELL SRL

Medium-wave diathermy treatment system

• Primary Device ID: 08056182721013
• NIH Device Record Key: 307fcd4e-e0c1-47d1-a1d9-ddf4cb377d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human Tecar
• Version Model Number: Straight Handpiece (Metallic connection)
• Catalog Number: 16476
• Company DUNS: 338736462
• Company Name: UNIBELL 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056182721013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181211

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: 2019-06-24
• Device Publish Date: 2019-06-15

On-Brand Devices [Human Tecar ]

• 08056182721136: Power cord US (120V/60Hz)
• 08056182721129: Power filter (rev2)
• 08056182721112: Remote control (HCR1002)
• 08056182721105: Steel Neutral Plate (Plastic connection)
• 08056182721099: Steel Neutral Plate (Metallic connection)
• 08056182721082: Cylindrical Indifferent Electrode (Plastic connection)
• 08056182721075: Cylindrical Indifferent Electrode (Metallic connection)
• 08056182721068: Straight Handpiece for Resistive Electrodes (Plastic connection)
• 08056182721051: Straight Handpiece for Resistive Electrodes (Metallic connection)
• 08056182721044: T-Shaped handpiece for Resistive Electrodes (Plastic connection)
• 08056182721037: T-Shaped handpiece for Resistive Electrodes (Metallic connection)
• 08056182721020: Straight Handpiece for Capacitive Electrodes (Plastic connection)
• 08056182721013: Straight Handpiece for Capacitive Electrodes (Metallic connection)
• 08056182721006: T-Shaped handpiece for Capacitive Electrodes (Plastic connection)
• 08056182720993: T-Shaped handpiece for Capacitive Electrodes (Metallic connection)
• 08056182720986: Low-impedance RES electrode Ø 90 mm
• 08056182720979: Low-impedance RES electrode Ø 65 mm
• 08056182720962: Low-impedance RES electrode Ø 50 mm
• 08056182720955: Low-impedance RES electrode Ø 35 mm
• 08056182720948: High-impedance CAP electrode, convex, lymphodynamic Ø 55 mm
• 08056182720931: High-impedance CAP electrode, convex, lymphodynamic Ø 40 mm
• 08056182720924: High-impedance CAP electrode, convex, thermodynamic Ø 65 mm
• 08056182720917: High-impedance CAP electrode, convex, thermodynamic Ø 55 mm
• 08056182720900: High-impedance CAP electrode, convex, thermodynamic Ø 40 mm
• 08056182720894: High-impedance CAP electrode, convex, thermodynamic Ø 30 mm
• 08056182720887: High-impedance CAP electrode, flat, thickened and lymphodynamic (forface) Ø 55 mm
• 08056182720870: High-impedance CAP electrode, flat, thermodynamic Ø 80 mm
• 08056182720863: High-impedance CAP electrode, flat, thermodynamic Ø 65 mm
• 08056182720856: High-impedance CAP electrode, flat, thermodynamic Ø 55 mm
• 08056182720849: High-impedance CAP electrode, flat, thermodynamic Ø 40 mm
• 08056182720832: High-impedance CAP electrode, flat, thermodynamic Ø 30 mm
• 08056182720283: HCR 1002 sales kit