Deka Lily
FDA 510(k) K233470 · El.En S.P.A.
510(k) numberK233470
Submission
- Device name
- Deka Lily
- Applicant
- El.En S.P.A.
Calenzano, IT - Received
- October 25, 2023
- Decision date
- December 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
Other 510(k)s with product code NGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253926 | DiacoreNGX · Traditional | ShenB Co., Ltd. | 04/10/2026SE |
| K253636 | Zionic Pro Max (EMS)NGX · Traditional | Termosalud S.L. | 03/12/2026SE |
| K253408 | CoolToneNGX · Traditional | Zimmer Medizinsysteme GmbH | 01/16/2026SE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)NGX · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 12/09/2025SE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003)NGX · Traditional | Motive Health, Inc. | 11/06/2025SE |
| K251594 | truFlexNGX · Special | Syrma Johari Medtech Limited | 08/28/2025SE |
| K251706 | TENS and EMS UnitNGX · Special | Changsha Anxiang Medical Technology Co., Ltd. | 07/30/2025SE |
| K251378 | CoolToneNGX · Special | Zimmer Medizinsysteme GmbH | 07/14/2025SE |
| K251746 | Pure ImpactNGX · Special | Sofwave Medical, Ltd. | 07/02/2025SE |
More from Sofwave Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260647 | SpecchioPBX · Special | 04/02/2026SE |
| K251432 | OloGEX · Traditional | 08/06/2025SE |
| K243683 | Deka BluebeamGEX · Traditional | 06/12/2025SE |
| K250281 | Deka LotusONF · Special | 02/26/2025SE |
| K241459 | MOTUS PRO FamilyGEX · Special | 06/21/2024SE |
| K240752 | Deka ToroGEX · Traditional | 05/16/2024SE |
| K233473 | Deka LotusONF · Traditional | 05/16/2024SE |
| K234057 | NirvanaGEX · Traditional | 04/10/2024SE |
| K240537 | Smartxide ProGEX · Special | 03/20/2024SE |
| K240497 | Smartxide Tetra ProGEX · Special | 03/12/2024SE |
Questions and answers
When was Deka Lily cleared by the FDA?
Deka Lily (K233470) received a 510(k) decision of Substantially Equivalent on December 19, 2023, 55 days after the submission was received.
What is the product code of K233470?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.