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Devices
Pressure IQ Evolve Mattress
Model / Serial
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. || Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Manufacturer
Arjo Hospital Equipment AB
1 Event
Recall of Pressure IQ Evolve Mattress
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Manufacturer
Arjo Hospital Equipment AB
Manufacturer Address
Arjo Hospital Equipment AB, HANS MICHELSENSGATAN 10, Malm¿ Sweden
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA
Language
English
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