FDA Registered Establishment
Hale Health is an FDA-registered establishment with device listings filed under 21 CFR Part 807. For U.S. cross-border procurement, FDA registration paired with Health Canada Class II is the standard regulatory floor on RLT panels.
Scope
- Establishment registration under 21 CFR Part 807
- Device listings filed for the RLPRO product family
- Public visibility through the FDA establishment database (FURLS)
- Shipment-level commercial-invoice declarations included on every U.S.-bound order
Why U.S. buyers ask for this
U.S. clinical-deployment buyers commonly require FDA establishment registration as a baseline qualification before they will entertain a panel deployment in a regulated clinical setting. The combination of Health Canada Class II plus FDA registration is the procurement signal that the device sits inside the medical-device regulatory perimeter on both sides of the border.
Verification path
Establishments are searchable in the public FDA database. We supply the registration number and the device listing detail directly on request as part of any procurement-grade documentation pack. Use the form on this page to receive a procurement-friendly one-page summary; certificate scans follow on request.
Where this fits
- Pairs with Health Canada Class II for the full cross-border regulatory pack.
- Anchor for enterprise deployments into U.S. multi-site operators.
- Required attachment for clinic deployments shipping cross-border.