Data / Medical devices / United States / Impact Innovations LLC
Impact Innovations LLC: FDA-registered device maker in Boca Raton, FL, United States, 2 510(k) clearances
Impact Innovations LLC is registered with the FDA (registration 3010759301) in Boca Raton, FL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 14, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010759301
- Address
- 123 Nw 13th St Ste 311, Boca Raton, FL, United States, 33432
- Owner or operator
- Impact Innovations LLC (10046402)
- Roles
- Specification developer
- First device listed
- March 18, 2014
- Registered through
- 2027
- Brand names listed
- ClearSpec, Kleengel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Specification developer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Specification developer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Specification developer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | 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 |
|---|---|---|---|---|---|---|
| September 14, 2015 | K143177 | KleenGel Dispenser | KYX | Substantially Equivalent | Kleengel, LLC | accessdata.fda.gov |
| August 6, 2013 | K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | HIB | Substantially Equivalent | Clearspec, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Liquid Medication
- All makers of Lubricant, Patient
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Speculum, Vaginal, Nonmetal
Updated September 14, 2015. 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.