Data / Medical devices / United States / Rinovum Subsidiary 2, LLC
Rinovum Subsidiary 2, LLC: FDA-registered device maker in Export, PA, United States, 1 510(k) clearance
Rinovum Subsidiary 2, LLC is registered with the FDA (registration 3015417614) in Export, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015417614
- Address
- 4923 Simmons Circle, Export, PA, United States, 15632
- Owner or operator
- Rinovum Subsidiary 2, LLC (10060129)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 2, 2019
- Registered through
- 2026
- Brand names listed
- Revive
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pessary, Vaginal | HHW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2019 | K183468 | Revive Reusable Bladder Support | HHW | Substantially Equivalent | Rinovum Subsidiary 2, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 2, 2019 | 83023 | Class II | Terminated | 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 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). | accessdata.fda.gov |
Compare with other makers
Updated January 25, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.