# K964460: The Robolite

- Pathway: 510(k) (Traditional)
- Applicant: Shai Syg Motion and Innovations, Ltd.
- Decided: Jan 24, 1997 after 78 days
- Product code: JQP (Calculator/Data Processing Module, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roboguide: named in the summary without a submission number

Source page: https://510kreport.com/device/K964460
Methodology: https://510kreport.com/methodology