3 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
FDA Enforcement
Class II
·Terminated·EHOB, Inc.·March 18, 2020
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.
FDA Enforcement
Class II
·Terminated·EHOB, Inc.·July 29, 2020
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
FDA Enforcement
Class II
·Ongoing·EHOB, Inc.·June 30, 2021