Is Your Wellness Product a Medical Device?

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→ Medical Device Claim
→ General Wellness Product
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YES NO YES NO YES NO YES NO ALL NO ANY YES YES NO ANY NO ALL YES Identify marketing claim Does the claim explicitly or implicitly reference diagnosis, treatment, prevention, mitigation, monitoring, or screening of a disease or condition? Claim reference a disease or condition ONLY in a context of lifestyle? General wellness ONLY with NO disease or condition reference? GENERAL WELLNESS CLAIMS ONLY: may help reduce risk OR may help living well with AND ONLY based on generally accepted science? Low Risk Technology Check ALL MUST BE NO: Invasive? Implanted? Hazardous tech? (laser, radiation, stimulation) Venipuncture / microneedles? FDA actively regulates product type? Physiological parameters involved? ALL MUST BE YES: Wellness-only use? No clinical thresholds? No alerts for medical action? No substitution for FDA-cleared device? Values validated if mimicking clinical MEDICAL DEVICE CLAIM GENERAL WELLNESS PRODUCT REF: "General Wellness: Policy for Low Risk Devices" issued on January 6, 2026
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