# K955034: Forceguard

- Pathway: 510(k) (Traditional)
- Applicant: Impact Monitors, Inc.
- Decided: Apr 10, 1996 after 160 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 K770405 (1977). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 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 1.
- K770405: Overload Warning Device, Synthes (Usa) (1977) Summary page 1.
- K792241: Pelimit, Colmed, Ltd. (1979) Summary page 1.

## Most influential descendants
- K023161: Smartstep System (2002), 1 descendant of its own
- K060150: Smartstep System/Smarstep Clinic System (2006), 0 descendants of its own

## Indications for use
ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value. ForceGuard will be used on patients whe have bore, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.

Source page: https://510kreport.com/device/K955034
Methodology: https://510kreport.com/methodology