Direct answer
That a general wellness product is one intended only for general wellness use and presenting low risk, and that some such products fall outside the statutory device definition.
Answer contract
Apply the definition lens only to the exact inspected source scope; do not infer authority from adjacent topics.
Evidence and exact locators
Inspected source 1 — Definition passage: the two factors defining a general wellness product; the following paragraph on products that do not meet the device definition under FD&C Act §201(h).. Supports: The bounded scope recorded in the reviewed specification.
What the evidence does not establish
A specification is not a route, a release, or a public page.
Rights and reuse
Rights basis recorded in the reviewed specification; link and bounded original paraphrase only.
Dependencies and related concepts
applies-to: urn:maha:concept:consent:wellness-recommendation-limits
governed-by: urn:maha:concept:governance
evidence-for: urn:maha:concept:consent
Questions this page can answer
What does US FDA CDRH, General Wellness: Policy for Low Risk Devices state about wellness-recommendation-limits?
That a general wellness product is one intended only for general wellness use and presenting low risk, and that some such products fall outside the statutory device definition.
Which exact locator in that source supports the claim on this page?
Inspected source 1, Definition passage: the two factors defining a general wellness product; the following paragraph on products that do not meet the device definition under FD&C Act §201(h).
What does this source explicitly not establish about wellness-recommendation-limits?
A specification is not a route, a release, or a public page.
Which canonical definition does this route depend on, and where is it owned?
applies-to: urn:maha:concept:consent:wellness-recommendation-limits governed-by: urn:maha:concept:governance evidence-for: urn:maha:concept:consent
What would have to be inspected before this page could claim more than it does?
A source, locator, rights, scope, boundary, dependency, implementation, or release change requires a new exact-revision review.