# K962591: Foot Weight Alarm

- Pathway: 510(k) (Traditional)
- Applicant: Cleveland Medical Devices, Inc.
- Decided: Dec 4, 1996 after 155 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 K915326 (1992). 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)
- K915326: Portable Limb Load Monitor (Bmllm-100), Bar Med Pty, Ltd. (1992) Summary page 1.

## Indications for use
The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern.

Source page: https://510kreport.com/device/K962591
Methodology: https://510kreport.com/methodology