General Wellness Product

PWC · Not classified · Unknown

Classification

FDA Product Code: PWC
Device class: Not classified
Regulation: —
Review panel: HO
Medical specialty: Unknown
Submission type: 7
GMP exempt: Y
Life sustaining: N
Implant: N
Third-party review: N

Definition

General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf

Market data

Cleared 510(k) submissions: 0
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown