FDA-Device2019-07-17Class II
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
Rinovum Women's Health
Hazard
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
Sold states
US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Affected count
1024 (180 distributed from distributor)
Manufactured in
300 Oxford Dr Ste 330, Monroeville, PA, United States
Products
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2019Don't want to check this manually?
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