Data / Medical devices / United States / Krenerb, LLC
Krenerb, LLC: FDA-registered device maker in Hockessin, DE, United States, 2 510(k) clearances
Krenerb, LLC is registered with the FDA (registration 3031464228) in Hockessin, DE, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031464228
- Address
- 503 Wilson Dr, Hockessin, DE, United States, 19707
- Owner or operator
- Krenerb, LLC (10090997)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 12, 2024
- Registered through
- 2026
- Brand names listed
- FlowKeepers, FlowKeepers Gel Pad Electrode Replacements, FlowKeepers Gel Pads
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| April 6, 2017 | K160323 | FlowKeepers | NGX | Substantially Equivalent | Dk Electronics, LLC | accessdata.fda.gov |
| July 25, 2014 | K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | GXY | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
Updated April 6, 2017. 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.