FDA device listing
9000 Jymni Pediatric Manual Wheelchair,Model 9000 Pediatric Manual Wheelchair
FDA device listing 1778257775 · Invacare Corporation dba Invacare America
Key facts
| Proprietary names | 9000 Jymni Pediatric Manual Wheelchair,Model 9000 Pediatric Manual Wheelchair |
|---|---|
| Owner/operator | Invacare Corporation dba Invacare America |
| Owner/operator number | 1525712 |
| Premarket submissions | K002170 |
| Product codes | IOR |
| Device names | IOR - Wheelchair, Mechanical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3850 |
| Review panels | Physical Medicine |
| Registered establishments | INVACARE CORP. DBA INVACARE AMERICA, INVAMEX S.DE R.L. DE C.V. |
| Establishment registrations | 1531186, 9616091 |
| FEI numbers | 1000253203, 3002889431 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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