The following data is part of a premarket notification filed by Medical Cables, S.l. with the FDA for Wiemspro.
Device ID | K181955 |
510k Number | K181955 |
Device Name: | WiEMSpro |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | Medical Cables, S.L. Duque De La Victoria 6, 1 Malaga, ES 29015 |
Contact | Jose Fuertes Pena |
Correspondent | Jose Fuertes Pena Medical Cables, S.L. Duque De La Victoria 6, 1 Malaga, ES 29015 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-23 |
Decision Date | 2019-02-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08435393716450 | K181955 | 000 |
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 |