FDA device listing
Everyday Activity Seat,Freestander,Horizon Stander,KID KART STROLLER,MIGHTY LITE STROLLER,MyGo…
FDA device listing 1612219782 · Sunrise Medical (US) LLC
Key facts
| Proprietary names | Everyday Activity Seat,Freestander,Horizon Stander,KID KART STROLLER,MIGHTY LITE STROLLER,MyGo Stander,Pronestander,Squiggles Plus Stander,Squiggles Seat,Squiggles Stander,Squiggles TT Stander,Totstander,VOYAGE |
|---|---|
| Owner/operator | Sunrise Medical (US) LLC |
| Owner/operator number | 9019832 |
| Product codes | INM |
| Device names | INM - Chair, With Casters |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3100 |
| Review panels | Physical Medicine |
| Registered establishments | Sunrise Medical Tecnologias, S.A. de CV, Sunrise Medical (US) LLC, SUNRISE MEDICAL (US) LLC |
| Establishment registrations | 2937137, 3019677893, 3039359026 |
| FEI numbers | 2937137, 3019677893, 3039359026 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract 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