FDA-Listed Device
The RLPRO panels are made by an FDA-registered manufacturer (Shenzhen Idea Light, FDA registration #3015287734) and are FDA-listed as a Class II infrared therapeutic lamp under 21 CFR 890.5500. For U.S. cross-border procurement, FDA listing paired with Health Canada Class II licensing is the standard regulatory floor on RLT panels. (FDA listing is not FDA clearance or approval — this device category is 510(k)-exempt.)
Scope
- Manufacturer establishment registration (Shenzhen Idea Light) under 21 CFR Part 807
- RLPRO panels FDA-listed as a Class II infrared therapeutic lamp (product code ILY, 21 CFR 890.5500)
- Publicly verifiable in the FDA registration & listing database (FURLS): registration #3015287734
- 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 the manufacturer's FDA establishment registration and device listing as a baseline qualification before they will entertain a panel deployment in a regulated clinical setting. The combination of Health Canada Class II licensing plus the manufacturer's FDA registration and device listing is the procurement signal that the device sits inside the medical-device regulatory perimeter on both sides of the border.
Verification path
The manufacturer's establishment is searchable in the public FDA registration & listing database (FURLS) under registration #3015287734 (Shenzhen Idea Light). We supply the full 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.