Data / Medical devices / General Wellness Product
General Wellness Product (PWC): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make General Wellness Product (product code PWC, Class N). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PWC
- Device class
- N
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| South Korea | 2 |
| China | 1 |
| Spain | 1 |
| India | 1 |
Makers of General Wellness Product
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aqp One, Inc. | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Careplix Healthcare LLC | Chicago, IL, United States | Complaint file establishment, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvilab Co., Ltd. | Incheon, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Sunwin Industry Group Co.,ltd. | Shanghai, China | Exporter to the US, Foreign private label distributor, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teckel Medical S.L. | Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watchyourhealth.com India Private Limited | Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellovate LLC | Boone, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiser Living | Seoul, South Korea | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.