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 |