510(k) K232334
- Device
- DEKA SIMON
- Applicant
- El.En S.P.A.
- 510(k) number
- K232334
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-01
- Date received
- 2023-08-04
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Paolo Peruzzi
- Address
- Via Baldanzese 17 Calenzano IT 50141 50141
FDA Registration Numbers
- 2031823
- 3010511300
- 3027718340
- 3012981024
- 1721293
- 9680487
- 3005868392
- 3015619973
- 3038197172
- 1644243
- 3033530347
- 3035374386
- 3003631667
- 3020683829
- 3022631685
- 3043657394
- 3010805941
- 9616877
- 3032062344
- 3038295706
- 3010583453
- 3010362721
- 3030151584
- 3004753827
- 3038138457
- 3009494725
- 3008048783
- 3012352782
- 8022189
- 3015588280
- 1055808
- 3011197543
- 3006850006
- 3017866822
- 3013671142
- 3004081884
- 3004733458
- 2024292
- 9612147
- 3013069546
- 3043153468
- 3015452693
- 3017936974
- 3014314933
- 3007731000
- 2026803
- 9616086
- 3027241812
- 1528764
- 3005621440
- 3019055598
- 9613347
- 3013375723
- 9710616
- 3010078417
- 3025235024
- 9710582
- 3007502541
- 1061158
- 1911273
- 3014315574
- 3004264602
- 3011782009
- 3023330992
- 3012386142
- 3008008477
- 3016670292
- 3005344585
- 8022890
- 3009437400
- 3031233199
- 3005095860
- 3043011436
- 3003740945
- 9613462
- 3013401749
- 3007543044
- 3005545216
- 9710580
Source Documents
Other 510(k) Records For Product Code IPF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 |