POWER-LOAD COT FASTENER SYSTEM— 510(k) K113598
Substantially EquivalentStryker Medical
FDA 510(k) clearance K113598 for POWER-LOAD COT FASTENER SYSTEM, Substantially Equivalent on 2011-12-20. Applicant: Stryker Medical. Device class: 2.
Clearance details
- Applicant
- Stryker Medical
- Product code
- Code FPO
- Device class
- Class 2
- Regulation
- 21 CFR 880.6910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code FPO
view allMore clearances from Stryker Medical
view allAdverse events under product code FPO
product code FPO- Death
- 29
- Injury
- 254
- Malfunction
- 5,054
- Other
- 10
- Total
- 5,347
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K113598
K-number listed on FDA's recall record- Z-1350-2019 — Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
- Z-1389-2018 — Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with 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 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
- Z-0566-2013 — The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113598.
Data sourced from openFDA. This site is unofficial and independent of the FDA.