The following data is part of a premarket notification filed by Hasomed Gmbh with the FDA for Rehastim 2, Rehamove 2.
| Device ID | K112844 |
| 510k Number | K112844 |
| Device Name: | REHASTIM 2, REHAMOVE 2 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | HASOMED GMBH PAUL-ECKE-STRASSE 1 Magdeburg, DE 39114 |
| Contact | Matthias Weber |
| Correspondent | Matthias Weber HASOMED GMBH PAUL-ECKE-STRASSE 1 Magdeburg, DE 39114 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-29 |
| Decision Date | 2011-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260397620168 | K112844 | 000 |
| 04260397620427 | K112844 | 000 |