The following data is part of a premarket notification filed by Curatronic, Ltd. with the FDA for Biomove 5000 System.
| Device ID | K080787 |
| 510k Number | K080787 |
| Device Name: | BIOMOVE 5000 SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CURATRONIC, LTD. 20 HATA ' AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein CURATRONIC, LTD. 20 HATA ' AS ST. Kfar Saba, IL 44425 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-04-17 |
| Summary: | summary |