Data / Medical devices / United States / MKJ Brands LLC
MKJ Brands LLC: FDA-registered device maker in Hackensack, NJ, United States, 2 510(k) clearances
MKJ Brands LLC is registered with the FDA (registration 3011360380) in Hackensack, NJ, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011360380
- Address
- 343 Anderson Street, Hackensack, NJ, United States, 07601
- Owner or operator
- MKJ Brands LLC (10089873)
- Roles
- Manufacturer
- First device listed
- February 3, 2025
- Registered through
- 2026
- Brand names listed
- Freshen-Up
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | 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 |
|---|---|---|---|---|---|---|
| November 18, 2021 | K212104 | Water-soluble Personal Lubricant | NUC | Substantially Equivalent | Foshan Pingchuang Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 18, 2021 | K202667 | Personal Lubricant Jelly | NUC | Substantially Equivalent | Nantong Health & Beyond Hygienic Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Disinfectant, Medical Devices
- All makers of Pad, Menstrual, Unscented
- All makers of Toothbrush, Manual
Updated November 18, 2021. 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.