Data / Medical devices / United States / Lotfancy Inc
Lotfancy Inc: FDA-registered device maker in Ontario, CA, United States, 6 510(k) clearances
Lotfancy Inc is registered with the FDA (registration 3010395155) in Ontario, CA, United States. It lists 19 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010395155
- Address
- 720 S Rochester Unit B, Ontario, CA, United States, 91761
- Owner or operator
- LOTFANCY INC (10044818)
- Roles
- Repackager or relabeler
- First device listed
- April 10, 2020
- Registered through
- 2026
- Brand names listed
- LOTFANCY, Lotfancy, MEDLOT, Medlot
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 11, 2024 | K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | LCX | Substantially Equivalent | Anhui Deepblue Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 16, 2023 | K220673 | Sterile Silver Alginate Wound Dressing | FRO | Substantially Equivalent | Qingdao Bright Moon Biomedical Materials Co., Ltd. | accessdata.fda.gov |
| December 2, 2019 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | FMK | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| November 22, 2017 | K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| May 11, 2017 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| December 16, 2010 | K102624 | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
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Updated October 11, 2024. 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.