FDA device listing
Carl 4 Foot R5,Carl 4 Foot R6,Carl 4 Foot R7,Carl 4 Heel R5,Carl 4 Heel R6,Carl 4 Heel R7,Carl Mk2 R5,Carl Mk2 R6,Carl…
FDA device listing 1578248635 · Rini Ergoteknik AB
Key facts
| Proprietary names | Carl 4 Foot R5,Carl 4 Foot R6,Carl 4 Foot R7,Carl 4 Heel R5,Carl 4 Heel R6,Carl 4 Heel R7,Carl Mk2 R5,Carl Mk2 R6,Carl Mk2 R7,Carl Mk2 R8,Carl Mk2 Without armrests,Carl Mk3E R7,Carl Mk3 R7,Carl Spring R6,Carl Spring R7,Carl Swing R6,Carl Swing R7 |
|---|---|
| Owner/operator | Rini Ergoteknik AB |
| Owner/operator number | 9046622 |
| Product codes | HMD |
| Device names | HMD - Chair, Ophthalmic, Manual |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1140 |
| Review panels | Ophthalmic |
| Registered establishments | RINI ERGOTEKNIK AB |
| Establishment registrations | 9710385 |
| FEI numbers | 3003138129 |
| Establishment operations | Manufacturer |
| 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