Data / Medical devices / United Kingdom / Savantini Holdings Limited
Savantini Holdings Limited: FDA-registered device maker in Hull East Riding of Yorkshire, United Kingdom, 1 510(k) clearance
Savantini Holdings Limited is registered with the FDA (registration 3006897018) in Hull East Riding of Yorkshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006897018
- Address
- Savantini House Foster Street, Hull East Riding of Yorkshire, United Kingdom, HU8 8BT
- Owner or operator
- Savantini Holdings Limited (10024217)
- Roles
- Manufacturer
- First device listed
- April 29, 2009
- Registered through
- 2026
- Brand names listed
- Kegel8 Ultra Core
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 12, 2008 | K081480 | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 | KPI | Substantially Equivalent | Ne Services , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2008. 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.