Data / Medical devices / United States / Love Wellness
Love Wellness: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Love Wellness is registered with the FDA (registration 3016116741) in New York, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 10, 2016. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016116741
- Address
- 166 Crosby Street Suite #201, New York, NY, United States, 10012
- Owner or operator
- Love Wellness (10092458)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- January 9, 2025
- Registered through
- 2026
- Brand names listed
- Love Wellness Antimicrobial Skin Cleanser Intimate Skin Support
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 10, 2016 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz | FRO | Substantially Equivalent | Simple Science, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 10, 2016. 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.