FDA product code PWC: General Wellness Product
PWC is the FDA product code for general wellness product. It is a Not classified device, reviewed by the General Hospital panel. Devices under PWC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for PWC devices, 1 initiated in the last five years.
Definition
General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
Classification
| Field | Value |
|---|---|
| Device name | General Wellness Product |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PWC devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-02-18.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code PWC?
PWC is the FDA product code for general wellness product. It is a Not classified device, reviewed by the General Hospital panel.
What device class is PWC?
Not classified. Typical premarket route: 510(k) exempt.
Have PWC devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2022-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code PWC
- Run a recall and safety report across every PWC manufacturer
- Watch product code PWC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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