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U.S. Department of Health and Human Services

Product Classification

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Device general wellness product
Definition General wellness product as detailed in the guidance for purposes of imports only: https://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.Pdf.
Physical State General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.
Technical Method General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.
Target Area General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.
Review Panel General Hospital
Product CodePWC
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type Enforcement Discretion
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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