The following data is part of a premarket notification filed by Medical Cables S.l. with the FDA for Wiemspro.
| Device ID | K211298 |
| 510k Number | K211298 |
| Device Name: | WiEMSpro |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Medical Cables S.L. Calle Ferrocarril Del Puerto 18 - Oficina 3-4 Málaga, ES 29002 |
| Contact | José Fuertes Peña |
| Correspondent | José Fuertes Peña Medical Cables S.L. Calle Ferrocarril Del Puerto 18 - Oficina 3-4 Málaga, ES 29002 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2022-08-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WIEMSPRO 88461982 5943460 Live/Registered |
MEDICAL CABLES SL 2019-06-06 |
![]() WIEMSPRO 87208061 not registered Dead/Abandoned |
Wiemspro SL 2016-10-19 |