FDA device listing
COMPANION SERIES 3 & 4 WHEELED SCOO,GC540 Companion Heavy Duty 3-Wheel Scooter,GC640 Companion Heavy Duty 4-Wheel…
FDA device listing 1549494577 · GOLDEN BROTHERS, INC.
Key facts
| Proprietary names | COMPANION SERIES 3 & 4 WHEELED SCOO,GC540 Companion Heavy Duty 3-Wheel Scooter,GC640 Companion Heavy Duty 4-Wheel Scooter,GOLDEN EAGLE GR595,Golden Patriot |
|---|---|
| Owner/operator | GOLDEN BROTHERS, INC. |
| Owner/operator number | 9925096 |
| Premarket submissions | K012258 |
| Product codes | INI |
| Device names | INI - Vehicle, Motorized 3-Wheeled |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.3800 |
| Review panels | Physical Medicine |
| Registered establishments | GOLDEN BROTHERS, INC. |
| Establishment registrations | 3008812160 |
| FEI numbers | 3008812160 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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