The following data is part of a premarket notification filed by Curatronic, Ltd. with the FDA for Biomove 3000.
| Device ID | K042650 |
| 510k Number | K042650 |
| Device Name: | BIOMOVE 3000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CURATRONIC, LTD. 4 ATSMON ST. Heshmonayim, IL 73127 |
| Contact | Arava Hacohen |
| Correspondent | Arava Hacohen CURATRONIC, LTD. 4 ATSMON ST. Heshmonayim, IL 73127 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2005-01-27 |
| Summary: | summary |