Identity
- Trade Name
- DEKA LILY FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- M135B1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08034108512495 FDA UDI
- 510(k) Number
- K233470 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Deka Lily by Deka M.e.l.a. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
- COMPEX — DJO, LLC · Class II
- RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
- BodyMed — BOXOUT, LLC · Class II
- veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
- Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
- iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
Sources (1)
- FDA UDI 1f5bef1b-4c73-4bda-9936-0390bebc7a07 34 fields · synced Jun 9, 2026