Readiness.

What the demo proves today, and which gates stand between a prototype and a live offer.

03 / Readiness register

Demonstrated today

A working demo. Visible gates.

This theme demonstrates how Shopify can present technical hardware, interactive product media, configurations, and an honest product narrative. It does not turn a prototype into a cleared or live product.

3D commerce: Native Shopify model media is supported when a development-store product is assigned. The current GLB is a validated presentation fallback.
Pricing: The displayed hardware price is a working target from evolving source material, not a public offer.
Regulatory: Potential FDA product-code fit remains under review. Classification of this specific hardware and software combination needs specialist confirmation.
Clinical: Compliance is inferred from cap-opening events, the proxy electronic monitoring caps have used for decades. No ingestion, clinical outcome, diagnosis, or treatment claim is made, and the signal is not clinically validated.
Launch: Authorized products, generated test data, privacy and security review, subscriptions, fulfillment, and checkout are still external gates.

External gate

Regulatory position, stated carefully.

FDA product code NXQ currently describes medication reminders as Class I and 510(k)-exempt, and FDA lists user-configured medication reminders among software functions under enforcement discretion. Neither fact establishes the classification of this specific hardware and software combination; specialist review remains an external gate.