The following data is part of a premarket notification filed by Otto Bock Healthcare Products Gmbh with the FDA for Myo Plus.
| Device ID | K191179 |
| 510k Number | K191179 |
| Device Name: | Myo Plus |
| Classification | Electrode, Cutaneous |
| Applicant | Otto Bock Healthcare Products GmbH Brehmstrabe 16 1110 Wien Vienna, AT |
| Contact | Rene Urtz |
| Correspondent | Rene Urtz Otto Bock Healthcare Products GmbH Brehmstrabe 16 1110 Wien Vienna, AT |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-02 |
| Decision Date | 2019-09-04 |
| Summary: | summary |