FDA device listing
Breezy,Drive,strongback mobility struck 24,strongback mobility struck transport,wheelchair foundation
FDA device listing 1615925073 · TAIWAN AN I CO.,LTD.
Key facts
| Proprietary names | Breezy,Drive,strongback mobility struck 24,strongback mobility struck transport,wheelchair foundation |
|---|---|
| Owner/operator | TAIWAN AN I CO.,LTD. |
| Owner/operator number | 9021165 |
| Premarket submissions | K052586 |
| Product codes | IOR |
| Device names | IOR - Wheelchair, Mechanical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3850 |
| Review panels | Physical Medicine |
| Registered establishments | A & I INDUSTRIES LTD, CC HSING COMPANY LIMITED, FA HORN TRADING INCORPORATED COMPANY |
| Establishment registrations | 3004034546, 3014273557, 3021327432 |
| FEI numbers | 3004034546, 3014273557, 3021327432 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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