Editorial still life of Hale regulatory documentation: open navy folder showing Health Canada Class II and FDA-listed certificates with red wax-seal badges, a Hale capability statement booklet, and a small olive tree on a beige linen surface in soft daylight.

Procurement-grade documentation

The Hale Proof Center.

Health Canada Class II. FDA-listed. A curated clinical evidence library. Every document an operator or compliance reviewer asks for, in one place.

Each download captures contact information so we can ship registration certificate scans and supporting evidence on request. No marketing email cascade.

Regulatory

Health Canada Class II

Medical Devices Regulations classification — the regulatory floor required for active photobiomodulation devices used in Canadian clinical practice.

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Regulatory

FDA-listed

U.S. Food and Drug Administration establishment registration and device listing under 21 CFR Part 807. Required for U.S. cross-border procurement.

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Procurement

Capability Statement 2026

One-page company snapshot — regulatory status, technical specifications, product family pricing, and procurement posture for RFP responses.

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Clinical

Clinical Evidence Library

A curated library of clinical photobiomodulation evidence — pain, recovery, brain and mood, safety, mechanism, skin. Sortable by condition.

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Where the Proof Center fits

Browsing for a single clinic? Start at the Clinic Deployment page — the Proof Center will arrive automatically in your confirmation email.
Scoping a multi-site network? Use the Proof Center alongside /for-businesses and /enterprise.
Looking for a specific clinical condition? Jump directly to the Clinical Evidence Library.