DEKA LILY

GUDID 08034108512495

The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The DEKA LILY is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin. The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H). Electrical requirements: 115V, 50/60Hz, 2300VA.

DEKA M.E.L.A. SRL

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08034108512495
• NIH Device Record Key: 1f5bef1b-4c73-4bda-9936-0390bebc7a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA LILY
• Version Model Number: M135B1
• Company DUNS: 629381096
• Company Name: DEKA M.E.L.A. 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034108512495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233470

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2024-09-25
• Device Publish Date: 2024-09-17

Devices Manufactured by DEKA M.E.L.A. SRL

• 08034108512464 - PRISMA: 2024-09-25 The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62
• 08034108512495 - DEKA LILY: 2024-09-25The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The DEKA LILY is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin. The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H). Electrical requirements: 115V, 50/60Hz, 2300VA.
• 08034108512495 - DEKA LILY: 2024-09-25 The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via el
• 08034108512730 - PRISMA EMS MODULE: 2024-09-25 The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveform
• 08034108512709 - DEKA SMARTXIDE PRO: 2024-04-17 The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tiss
• 08034108512808 - SMARTXIDE TETRA PRO: 2024-04-16 The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser ener
• 08034108512846 - Scar 3 PRO: 2024-04-12 The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Scar 3 is composed of the followin
• 08034108512655 - Elite iQ PRO: 2024-03-21 The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is define
• 08034108512525 - AGAIN PRO: 2023-11-08 The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sou