The following data is part of a premarket notification filed by Shai Syg Motion And Innovations, Ltd. with the FDA for The Robolite.
| Device ID | K964460 |
| 510k Number | K964460 |
| Device Name: | THE ROBOLITE |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
| Contact | ELI ORBACH |
| Correspondent | ELI ORBACH SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1997-01-24 |