# K113598: Power-Load Cot Fastener System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Medical
- Decided: Dec 20, 2011 after 15 days
- Product code: FPO (Stretcher, Wheeled)
- Device class: 2
- Regulation: 21 CFR 880.6910
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942948 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072598: Irsg I-Mover for Beds, International Retail Services Group, LLC (2008) Summary page 1.

## Recalls of this device
- Nov 20, 2018 · Class II · Z-1350-2019: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- Mar 12, 2018 · Class II · Z-1389-2018: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- Oct 11, 2012 · Class II · Z-0566-2013: Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the 

## Indications for use
The Power-LOADTm cot fastening system (model 6390) is intended to assist wit loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 Ibs, which includes the weight of the ambulance cot, patient, and equipment attached to the cot (i.e. oxygen bottles, monitors, and/or pumps). The intended users of the device will be trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. The expected service life of the product is 7 years.

Source page: https://510kreport.com/device/K113598
Methodology: https://510kreport.com/methodology