DEKA LILY
Basic Information
- Brand Name
- DEKA LILY
- Primary DI
- 08034108512495
- Version / Model
- M135B1
- Company Name
- DEKA M.E.L.A. SRL
- Labeler DUNS
- 629381096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-17
- Public Version
- 1
- Public Version Date
- 2024-09-25
- Public Version Status
- New
- Public Device Record Key
- 1f5bef1b-4c73-4bda-9936-0390bebc7a07
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034108512495 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233470 | 000 |