510(k) K243165
- Device
- Limfa Therapy System (Limfa Therapy)
- Applicant
- Eywa Srl
- 510(k) number
- K243165
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-15
- Date received
- 2024-09-30
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tommaso Faiella
- Address
- Via Pietrarubbia N. 25/E N. 25/E Rimini IT 47922 47922
FDA Registration Numbers#
- 3011767724
- 3042971880
- 3001431138
- 3016832824
- 9611558
- 3023808190
- 3015529344
- 3015889734
- 8010720
- 3009488655
- 3008753275
- 9617486
- 3032062344
- 3014774380
- 3035374386
- 3048246437
- 3004940677
- 3026753375
- 3010852191
- 3015781781
- 3016170453
- 3003446042
- 3016674228
- 9613462
- 3011562129
- 3003678958
- 3014647250
- 8040537
- 3007731000
- 1061158
- 3030970133
- 3012386142
- 3009494725
- 3013613043
- 1832894
- 3012316249
- 3025379728
- 3021635975
- 3042351542
- 3027605507
- 3007092044
- 3010405397
- 3026400760
- 3023339107
- 3011077581
- 3010078417
- 3038620598
- 3038189188
- 3015214304
- 1528161
- 3045753434
- 3029939996
- 3007502541
- 3038295706
- 3042268484
- 3037609256
- 3020769982
- 3010427504
- 3011564440
- 3012176966
- 3022929665
- 3021315370
- 3015452693
- 9616877
- 3033530347
- 3012840029
- 3026164517
- 3030412027
- 3019822804
- 3012651177
- 3030220267
- 3033273466
- 3024182169
- 3010632563
- 3010402752
- 3027645761
- 3031464228
- 3013503862
- 3042953831
Source Documents#
Other 510(k) Records For Product Code NGX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | 2026-08-13 |
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026-03-12 |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026-01-16 |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025-11-06 |
| K251594 | truFlex | Syrma Johari Medtech Limited | 2025-08-28 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025-05-30 |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 |