The following data is part of a premarket notification filed by Hasomed Gmbh with the FDA for Rehastim 2.
| Device ID | K162683 |
| 510k Number | K162683 |
| Device Name: | RehaStim 2 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | HASOMED GmbH Paul-Ecke-Str. 1 Magdeburg, DE 39114 |
| Contact | Matthias Ueltzen |
| Correspondent | Matthias Ueltzen HASOMED GmbH Paul-Ecke-Str. 1 Magdeburg, DE 39114 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260397620410 | K162683 | 000 |