FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
DEKA LILY
K Number: K233470
·
Decision Dec 19, 2023
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
15
Review Days
55
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DEKA LILY
- K Number
- K233470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- El.En S.P.A.
- Date Received
- October 25, 2023
- Decision Date
- December 19, 2023
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGX), ordered by most recent decision date.
Diacore
FDA 510(k)
FDA Class 2
·Physical Medicine
Zionic Pro Max (EMS)
FDA 510(k)
FDA Class 2
·Physical Medicine
CoolTone
FDA 510(k)
FDA Class 2
·Physical Medicine
Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
FDA 510(k)
FDA Class 2
·Physical Medicine
Motive Muscle Stimulator for Lower Back (OT01-1003)
FDA 510(k)
FDA Class 2
·Physical Medicine
truFlex
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by El.En S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K260647 | SPECCHIO | Apr 2, 2026 | Substantially Equivalent |
| K251432 | Olo | Aug 6, 2025 | Substantially Equivalent |
| K243683 | Deka Bluebeam | Jun 12, 2025 | Substantially Equivalent |
| K250281 | DEKA LOTUS | Feb 26, 2025 | Substantially Equivalent |
| K241459 | MOTUS PRO Family | Jun 21, 2024 | Substantially Equivalent |
| K240752 | DEKA TORO | May 16, 2024 | Substantially Equivalent |
| K233473 | DEKA LOTUS | May 16, 2024 | Substantially Equivalent |
| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent |
| K240497 | Smartxide Tetra Pro | Mar 12, 2024 | Substantially Equivalent |