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 |