# K960307: Index Shoe

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Technology Research, Inc.
- Decided: Jun 27, 1996 after 157 days
- Product code: IRN (Device, Warning, Overload, External Limb, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882974 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882974: Force Guard I, Boulder Impact Monitors, Inc. (1988) Summary page 4.

## Indications for use
The AccuTread™ Shoe is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities.

Source page: https://510kreport.com/device/K960307
Methodology: https://510kreport.com/methodology