FDA device listing

BrightBrainer Console System

FDA device listing 1345563663 · Bright Cloud International Corp

Key facts

Proprietary names BrightBrainer Console System
Owner/operator Bright Cloud International Corp
Owner/operator number 10050478
Product codes ISD
Device names ISD - Exerciser, Measuring
Device class Class II
Classification regulations (21 CFR) 890.5360
Review panels Physical Medicine
Registered establishments BRIGHT CLOUD INTERNATIONAL CORP.
Establishment registrations 3012187972
FEI numbers 3012187972
Establishment operations Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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