# K971046: Handiflex

- Pathway: 510(k) (Traditional)
- Applicant: Handiflex Corp.
- Decided: Sep 16, 1997 after 179 days
- Product code: JFB (Table, Physical Therapy, Multi Function)
- Device class: 2
- Regulation: 21 CFR 890.5880
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints. The user can exercise different muscle groups at different degrees of inclination.

Source page: https://510kreport.com/device/K971046
Methodology: https://510kreport.com/methodology