General Wellness Product
The General Wellness Product encompasses devices that promote general health and well-being without making specific medical claims, as defined by FDA's General Wellness Policy, and this product code is designated specifically for import classification purposes. It is classified as unclassified (device class N) with no regulation number assigned, and is GMP exempt per its unclassified reason code. The product code is PWC, reviewed under the General Hospital panel, and it is not flagged as an implant or life-sustaining device. As a general wellness product it is not subject to the same marketing controls as FDA-regulated medical devices.
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Basic Information
- Product Code
- PWC
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.