Data / Medical devices / United States / Winx Health Inc
Winx Health Inc: FDA-registered device maker in Reading, PA, United States, 4 510(k) clearances
Winx Health Inc is registered with the FDA (registration 3015729142) in Reading, PA, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015729142
- Address
- 184 Tuckerton Rd Unit 2, Reading, PA, United States, 19605
- Owner or operator
- Winx Health Inc (10061060)
- Roles
- Repackager or relabeler
- First device listed
- August 7, 2019
- Registered through
- 2026
- Brand names listed
- Stix Condoms, Stix Early Pregnancy Test, Stix Ovulation Test, Stix Pantyliner, Stix UTI test, Stix Vaginal pH Test, stix pregnancy test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Paper, Obstetric Ph | LNW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | 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 |
|---|---|---|---|---|---|---|
| August 7, 2015 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 20, 2004 | K041273 | ONE-STEP PREGNANCY TEST | LCX | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| March 21, 2000 | K994312 | MALE LATEX CONDOM 56MM | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Menstrual, Unscented
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Test, Urine Leukocyte
- All makers of Paper, Obstetric Ph
Updated August 7, 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.